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Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as remotely anywhere in the USA as a Senior Manager, Statistical Programming or in our Bridgewater, New Jersey, USA on-site location,

Key Accountabilities:

Coach, mentor, develop, provide technical review, advice and expertise to direct subordinate Statistical Programmers as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.

Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.

Participate in the development and maintenance of standards for database design by defining standard database modules, variable names, attributes, and associated data validation/logical checks

Participate in the development and maintenance of standards for SAS datasets of clinical trial data, including but is not limited to, raw and derived datasets from Everest databases or acquired from sponsors or 3rd party vendors. The dataset standards will address standardization in dataset structure and names, variable attributes and definitions, documentation such as files of dataset define.doc.

Perform a leadership role in statistical programming and reporting with focuses on planning and execution of programming tasks involving standardized summary tables, listings, and graphs using established standard mockups and SAS programs/macros. When required this effort will cover all standard and non-standard subject data listings and graphs, as well as SAS logical checks and batch editing of clinical trial data. This leadership role will involve in the planning, leading, assessing, project management and reporting the progress status of the assigned projects, and contributing to the performance evaluation of project team members.

Lead programming efforts for assigned client clusters.

Provide mentorship and technical supervision to the statistical programming project team members of responsible projects. Monitor the compliance of and adherence to the established standards by reviewing the programs and outputs from the project team members assigned to the responsible projects.

Follow up on the industry trends in data and programming standardization, and good programming working practices. Follow up on the latest technologies, consult with clients, upper management, peers, and subordinates to evaluate, recommend, and implement improvements to the existing company standards and good working practices.

Participate in the development of statistical programming SOPs, guidelines, and good working practices.

Assist in recruiting and developing of statistical programmers.

Provide initial orientation training to Statistical Programmers and Biostatisticians.

Lead the efforts to plan and execute archiving of the statistical programming information upon completion of the project and transfer of the archives to the sponsor.

Perform the job accountabilities of a Principal Statistical Programmer, and assist statistical programming management in managing statistical programming projects, interacting with clients, and providing day to day close supervision of statistical project team members.

Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.

Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning, and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.

Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.

Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.

Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.

Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.

Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.

Perform 3rd level QC review on programming deliverables before their release to the clients.

Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.

May lead programming efforts for drug development programs or for assigned client clusters.

Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.

May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.

Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.

Participate in statistical programming project bidding or bid defense meetings.

Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors.

Qualifications and Experience:

M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.

Minimum 9 years' experience with in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.

Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com.

Estimated Salary Range: $150,000 - $190,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

#LI-Remote

#LI-TK1

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Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

Senior Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.

Senior Managers of Statistical Programming also support and lead improvement initiatives. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Senior Managers also lead and support the change management process (e.g. communication, training, stakeholder engagement).

This position may include functional management responsibilities. In this role, Senior Managers of Statistical Programming are responsible for managing employees: set objectives, manage performance, and provide meaningful coaching and feedback. They also support the evaluation and recruitment of potential employees.

Key Responsibilities

Project Responsibilities:

Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
Leads / Supports the electronic submission preparation and review
Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
Communicates proactively and effectively around issues and risks and contributes to its remediation

Improvement Responsibilities:

Identifies, leads, and supports opportunities to enhance processes and technology
Communicates proactively and effectively around issues and risks and contributes to its remediation

Managerial Responsibilities (if applicable):

Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS
Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager
Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
Communicates with manager regarding promotions, performance concerns, and retention risks
Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results

Minimum Requirements:

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 7 years programming experience in industry including support of significant regulatory filings
For US positions: US military experience will be considered towards industry experience
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
Broad expertise in statistical programming and in developing computing strategies
In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)
Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)
Demonstrated ability to work in a team environment with clinical team members

Preferred Requirements:

Management experience supervising technical professionals

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Remote - United States - US: $145,320 - $176,099\n

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Key Responsibilities

Project Responsibilities:

Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
Leads / Supports the electronic submission preparation and review
Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
Communicates proactively and effectively around issues and risks and contributes to its remediation

Improvement Responsibilities:

Identifies, leads, and supports opportunities to enhance processes and technology
Communicates proactively and effectively around issues and risks and contributes to its remediation

Managerial Responsibilities (if applicable):

Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS
Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager
Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
Communicates with manager regarding promotions, performance concerns, and retention risks
Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results

Skills, knowledge, and experience

Minimum Requirements:

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 8 years programming experience in industry including support of significant regulatory filings
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
Broad expertise in statistical programming and in developing computing strategies
In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)
Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)
Demonstrated ability to work in a team environment with clinical team members

Preferred Requirements:

Management experience supervising technical professionals

On-site Protocol

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

","hiringOrganization":{"@type":"Organization","name":"Bristol Myers Squibb","sameAs":"https://www.bms.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hyderabad, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":4,"item":{"@type":"JobPosting","title":"Senior Manager - Statistical Programming (Remote)","datePosted":"2025-08-25","description":"

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.

Responsibilities

Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff.
Participates in the recruitment and selection of new staff.

*This position can be hybrid working out of Lake County, IL; Irvine, CA; San Francisco, CA; Florham Park, NJ. Open to candidates working fully remote anywhere in the US *

Qualifications

Minimum Qualifications:

MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Minimum of 2 years experience leading a team of statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.

Additional Information

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

","hiringOrganization":{"@type":"Organization","name":"AbbVie","sameAs":"https://www.abbvie.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"North Chicago, IL, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":5,"item":{"@type":"JobPosting","title":"Senior Manager, Statistical Programming (REMOTE)","datePosted":"2025-09-03","description":"

Company Description

Job Description

Purpose

Responsibilities

Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff.
Participates in the recruitment and selection of new staff.

Qualifications

*This position is eligible to work remote anywhere in the US

Qualifications

MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Minimum of 2 years experience leading a team of statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $121,000 - $230,000
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

","hiringOrganization":{"@type":"Organization","name":"AbbVie","sameAs":"https://www.abbvie.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"North Chicago, IL, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":6,"item":{"@type":"JobPosting","title":"Director Statistical Programming","datePosted":"2025-08-11","description":"

Band

Level 6

Job Description Summary

Novartis SP-AQS (Stat. Programming, Analytics and Quantitative Science) is looking for a candidate with a solid experience in clinical trials data Stat., programming (data derivation, Health authorities requirements understanding, disease area skills) combined with a strong experience in diverse programming language: SAS and open source for enhanced capability programs (R, Python...)

Job Description

Solid experience in clinical trials data Stat. programming combined with a strong expertise in diverse programming language: Open source : R, Python and SAS to support the SP global group transitioning and diversifying their skills.
As a functional leader of AQS, acting with an enterprise mindset, fully involved in all aspects of Statistical Programming including the development of future strategies and processes. Contributes to the further development of the AQS organization with a focus on continuous improvement and quality by fostering statistical programming innovations, processes and solutions that ensure efficient implementation and knowledge sharing across Novartis.
Understands the needs and expectations of the different Health Authorities, ensures audit readiness and participates in Health Authority inspections. Monitors all assigned projects within DU/sub-function which includes BR/GMA, complying with Novartis, AQS and industry standards (e.g. CDISC) and processes.
Builds and establishes a strong team (with or without direct report) based on technical agility, capability, quality focus, excellence in performance and Novartis values and behaviors. Ensures the team addresses compliance matters in a timely way.
Leads and supports global clinical and non-clinical projects and initiatives to drive functional excellence within AQS,
Ensures high quality communication and information flow on status of all deliverables to stakeholders, mitigates and manages risks
Set vision, strategy and direction for respective functional unit within statistical programming.
Drive productivity and efficiency measures to meet Novartis strategic imperatives and productivity targets.
Actively ensures that metrics for teams performance are in place and being met or exceeded.
As a member of the Statistical Programming Leadership Team is fully involved in all aspects of Statistical Programming Operations and helps develop future strategies and inputs on processes.
Contributes to the further development of the Statistical Programming organization with a focus on continuous improvement by ensuring statistical programming innovations, foster statistical programming solutions and ensuring their efficient implementation and knowledge sharing across Novartis.
Ensures that team are tracking time in order to further evaluate business needs with regard to capacity forecasting and increasing productivity -Builds and establishes a strong team spirit and creates a team founded on technical ability, excellence in performance and Novartis values and behaviors.
Leads and supports global clinical and non-clinical special projects and initiatives to drive functional excellence -Ensures high quality communication and information flow on status of all deliverables to stakeholders, mitigates and manages risks -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:

+15 yrs experience
University or college degree in life science, computer science, statistics or other relevant field.
Proven leadership, collaboration and organizational skills with demonstrated ability to successfully manage simultaneous deliverables and meet deadlines
Excellent understanding of clinical trial methodology, GCP and medical terminology

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Skills Desired

Clinical Trials, Computer Programming, Cross-Functional Teams, Data Science, Data Structures, Initiative, People Management, Programming Languages, Statistical Analysis, Waterfall Model","hiringOrganization":{"@type":"Organization","name":"Novartis","sameAs":"https://www.novartis.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Basel (City), Switzerland","addressCountry":"Switzerland","addressRegion":"Europe"}}}},{"@type":"ListItem","position":7,"item":{"@type":"JobPosting","title":"Statistical Programming Lead","datePosted":"2025-08-07","description":"

\n \n General Information\n

\n\n\n\n\n\n\n Job Advert Title\n \n\n Statistical Programming Lead\n \n\n\n\n Location\n \n\n United Kingdom\n \n\n\n\n Function/Business Area\n \n\n Research\n \n\n\n\n Employment Class\n \n\n Permanent\n \n\n\n\n\n\n\n

\n \n Description\n

\n\n\n\n\n\n\nStatistical Programming Lead
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
We have an exciting opportunity for a Statistical Programming Lead to join our new hub Data Science team in the UK to work within our established Data Science/Statistical & RWD division on a global scale alongside over 200 team members internationally.
As a Statistical Programming Lead, you will be responsible for programming vendor oversight for assigned compounds and contributing to functional/departmental infrastructure projects.
You will also be assigned to the most complex tasks, offer training/mentoring to other programmers, and lead assigned Statistical Programming and Data Science strategic objectives and drive implementation of relevant functional objectives.
Key Activities for this role:

Is responsible for the production of high-quality, on-time statistical programming deliverables (such as datasets and tables/listings/figures (TLFs). Ensures that integrated programmed deliverables are ready to be used in regulatory submissions and follow Astellas, industry and regulatory standards.
Directly leads the internal programming team for insourced work; for outsourced work, the position liaises with the lead at the vendor.
Provides regular oversight of statistical programming work outsourced to Full-Service Providers (FSPs) and acts as a liaison between the FSP and Astellas.
Recognizes and addresses issues that may impact the validity or completeness of the deliverables
Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - implement novel statistical software - standard output generation - creation of, maintenance and adherence to indication-specific standards).

Essential Knowledge & Experience:

Relevant experience as senior/principal lead programmer for a drug development program gained within the pharmaceutical or a related industry and exposure to working with vendors.
Substantial years of experience of relevant programming experience in the pharmaceutical industry and working with vendors
An understanding of the data science lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization.
Responsible for the high-quality, on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)),
Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines
The ability to read, analyse, and communicate large and small amounts of data efficiently, including teaching/explaining data-driven results to others.

Education/Qualifications:

Bachelor’s or master’s in statistics, mathematics, or a related field.

Additional information:

This is a permanent, full-time position based in the UK.
We offer a hybrid working pattern, requiring one day per quarter in the office (Addlestone), blended with a collaborative video environment that supports working from home.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
#LI-Addlestone#LI-Hybrid#LI-JS1
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ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director, Statistical Programming on a permanent basis.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Responsible for the setup and monitoring of the assigned projects.
Managing the overall project to ensure the deliverables meets the required quality and timeline.
Conduct the meetings with statisticians and programmers for business needs.
Manage resources throughout the life cycle of projects.
Manage programming teams to support projects.
Coordinate client activities related to the projects.
Develop and implement standard operating procedures for programming operation.
Lead or support electronic submission as needed.
Innovative and able to take initiatives and follow through in programming workflow optimization.
Hire, train, and mentor statistical programming staff.

Education and Experience:

Requires a BS or MS degree in computer science, statistics, or related field with 6+ years of management experience.
Must be experienced in clinical trial settings.
Excellent problem-solving skills and work independently.

Our Benefits:

Flexible Working Hours
Full performance and development process with end of year reviews
Team events and end of year party
Employee satisfaction survey - your feedback is important for continuous improvement
Health Insurance

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities

Lead the management team to ensure that resources (processes, procedures, personnel etc) optimally support the business requirements of the function
Ensure that the department has a well-organized infrastructure and adequate resources to enable projects to be completed on time and within budget.
Provide accurate forecasting figures for the annual budgeting process and manage throughout the year to ensure that the budgetary goals are met or exceeded.
Provide expertise and consultation, facilitate metrics collection and develop action plans in conjunction with Project Leader/Lead to keep projects on time and within budget.
Drive team members to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures.
Ensure agreed levels of productivity/billability and staff turnover are maintained.
May be responsible to coordinate client or account activities for department or function.
May serve as GMBA for a location or country.
Participate in and contribute to project bids, including client presentations. Provide on-going support to Portfolio Management and Business Development groups.
Ensure percentage of travel and billability guidelines for department, region or function, are met where appropriate.
Act as executive oversight of a large project where applicable.
Act as the client contact for local business when required.
Manage multiple countries and/or subcontractors.
Follow up departmental metrics, drive team members to meet departmental goals
Ensure management team check quality of department deliverables (e.g., site visits, Central File documentation) and take appropriate remedial action.
Ensure departmental or functional training plans in place and appropriate
Revise, implement and monitor departmental compliance with SOPs.
Ensure implementation of process improvements in response to client and team feedback and quality audits.
Participate in committees, task force groups as needed.
Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and Parexel.
Work with senior departmental management in developing managers and ensuring a talented pipeline of management staff within the department or function.
Performs a leadership role in ensuring managers and staff are communicating and coordinating efforts to provide superior line management services to staff.
Demonstrate excellent leadership skills within department, function or location. This includes taking an active role in departmental, functional or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate.
Train and mentor new managers
Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel WSOPs.
Participate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
Participate in PXL and department system/standards improvement activities.
Support efforts for generating business leads (client networking, public speaking, etc.).
Departmental or Project tasks as assigned.
Travel as needed

Skills

Advanced ability to manage and motivate direct reports
Advanced ability to successfully manage a full workload across multiple-projects.
Demonstrated strength in managing Managers and leading diverse teams
Outstanding negotiation and organizational skills.
Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer.
A flexible attitude with respect to work assignments and new learning
Advanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Ability to work in a matrix environment and to value the importance of teamwork.
Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook.
Excellent negotiation skills
Excellent analytical and problem-solving skills

Education

Educated to a degree level (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent

Language Skills

Competent in written and oral English and local language

Minimum Work Experience

Significant work experience including substantial management experience.

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Position Summary:

The Director, Statistical Programming will be responsible for leading and directing the statistical programming team and strategy for clinical projects across one or multiple therapeutic areas. Ensure delivery of high-quality programming deliverables in project timelines. Statistical Reporting representative on major Apellis initiatives.

Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

Operational and functional leadership of one or multiple therapeutic areas (TA).
Lead and implement the statistical programming strategy in the responsible therapeutic area/s.
Recruit, develop, mentor, coach people managers responsible for managing individual drug projects. Appraise the performance of direct and indirect reporting associates. Ensure high quality performance management and associates’ career development within his/her TAs.
Establishes high expectations and goals to ensure organizational success. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
Manage quality, timeliness, efficiency, and implementation of standards within his/her Unit. Ensure implementation of state-of-the-art programming practices and quality guidelines in compliance with regulatory requirements and Apellis quality standards, to ensure programming deliverables of high quality, on time, and within budget.
Build and maintain strong partnerships within Apellis Statistical Programming groups and across functions within Biometrics, Regulatory and all development functions.
Attend Biometrics leadership meeting and extended leadership meeting to represent programming function on strategic and operational level.
Lead all external and internal resource management activities across programming TAs, as well as contribute to the overall resource planning for programming.
Manage and builds relationships with external partners and service organizations. Engages in effective management of vendors including development, maintenance and monitoring of effective KPIs and KQIs.
Anticipates potential problems within and across TAs and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels.
Lead independently improvement initiatives and/or non-clinical projects for programming and Biometrics.
Ensure that relevant SOPs/BGs/Working practices are in place and followed.
Review the planned contents of tables / listings / figures for SCS/SCE and project level documents to ensure efficient production and usefulness of output.
Lead/participate in external industry/statistical programming activities and forums like PharmaSUG, SUGI, PHuse etc.

Education, Registration & Certification:

Post-graduate university or college degree in Life Sciences, Statistics, Mathematics, Computer Science, Medical Informatics or equivalent.

Experience:

12+ years of experience in global drug development, including at least 8 years in a senior programming/statistical role within the pharmaceutical industry.
Strong leadership skills including leading people, operations, and innovation globally in complex matrix structures and business models.
Superior interpersonal skills.
At least 5 years of people management experience of staff across multiple sites.
Good knowledge of drug development and commercialization processes.
Proven ability to proactively identify issues, recommend and implement solutions.
Strong global project management skills / Track record in successful project management.
Good knowledge of statistical programming languages like SAS, R and R Shiny

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

Up to 15% travel expected.

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/benefits/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

","hiringOrganization":{"@type":"Organization","name":"Apellis Pharmaceuticals","sameAs":"https://apellis.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Waltham, Massachusetts, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":11,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming","datePosted":"2025-07-16","description":"

The Associate Director of Statistical Programming, as a member of the Biostatistics & Statistical Programming Department, will contribute to Alkermes to achieve the goals of continuing growth in neuroscience. The Associate Director will combine technical and project management skills to lead programmers to develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in CDISC compliance to meet regulatory requirements. In addition, this individual will support the automation and innovation within programming group to drive effective and efficient statistical programming.

This is a hybrid, on-site position based in Waltham, MA.

Primary Responsibilities

Function as lead programmer to coordinate all activities related to study or project level statistical programming activities.
Design and develop programming specifications and SAS programs for producing and validating CDISC compliant datasets to support the generation of outputs for regulatory submission.
Produce and validate regulatory submission tables, figures and listings, support ad-hoc exploratory analysis in a timely fashion and of high quality
Design, develop, implement and maintain innovative statistical programming automation reporting tools to effectively support multiple projects.
Provide project management and technical guidance to ensure operational and technical excellence. Mentor junior level staff in programming practices, implementation of standards and project management.
Represent statistical programming in cross-functional teams. Work in close collaboration with other functions including biostatistics, clinical operations, data management and regulatory operations to define deliverables, develop timelines and ensure alignment of expectations
Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting

Basic Requirements

Advanced degree strongly preferred (M.S. or Ph. D) with strong analytical skills
Minimum 8+ years experiences in pharmaceutical/biotech and/or CRO setting

Preferred Requirements

Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc.
Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions. Strong hands-on SAS programing skills for clinical trial reporting. Experience with electronic FDA submission.
Prefer proficiency in other data analysis programming languages, such as R and Python. Ability to learn new programming language quickly and be motivated to utilize them in the clinical development field.
Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Strong interpersonal, organizational, and multi-tasking skills
Excellent attention to detail and problem-solving skills
Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
Good written and oral presentation skills and ability to communicate effectively
Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
Neuroscience experience is a plus
SAS LSAF experience is a plus

\n\n\n\n

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

\n\n\n
\n\n\n

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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Band

Level 5

Job Description Summary

The Early Development, Associate Director, Statistical Programming , is responsible for all statistical programming aspects of one or more drug development programs or indication programs with Early Development space.

As a program lead, the Associate Director ensures cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug life cycle management. They ensure that the assigned trials/programs are adequately resourced, and oversee all aspects of programming, quality and regulatory compliance.

This key leadership position ensures the efficient execution of trial/program level plans, delivering high-quality results on time. A thorough understanding of the drug development process, experience in regulatory activities, and expertise in statistical reporting, along with a proven track record in operational or functional leadership, is required.

Job Description

Lead SP activities for multiple clinical trials within a program or an indication /disease area. Experience in one of the TA areas: Immunology, Cardiovascular & Metabolic Diseases and Neuroscience is must.
Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s).
Responsible for allocating resources within a program and ensuring resource sharing between programs to meet Advanced Quantitative Science and organizational goals.
Recruit, mentor, and nurture statistical programmers. Conduct performance appraisal of direct reports, as applicable.
Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan).
Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training.
Represent SP (Early Development) at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC).

Experience:

In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met.
BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree. Must also be fluent in English
Must have early development experience, ideally in Oncology
Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.
Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions.
Matrix or people management of approximately 6-15 internal or external programmers. Depending on role, may act as a functional/operational manager of associates or may be an individual contributor with no direct reports.
Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs.
At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers. Ideally, 10+ years of industry experience, with at least 6 years in a programming or statistical role. At least 3 years of line management or equivalent leadership experience, such as matrix management (applicable for people managers only).

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? : https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network:

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Programming Languages, Reporting, Statistical Analysis, Waterfall Model","hiringOrganization":{"@type":"Organization","name":"Novartis","sameAs":"https://www.novartis.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"London (The Westworks), United Kingdom","addressCountry":"United Kingdom","addressRegion":"Europe"}}}},{"@type":"ListItem","position":13,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming","datePosted":"2025-08-05","description":"

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do: Reporting to the Senior Director, Statistical Programming, the Associate Director will provide statistical and clinical data programming expertise to manage statistical programming activities that support drug development programs and regulatory submissions. This role involves overseeing the creation, validation, and delivery of programming deliverables, ensuring compliance with industry standards, and fostering cross-functional collaboration with biostatistics, data management, clinical, and regulatory teams.  

Responsibilities:

Oversee the development and validation of SAS programs to generate datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in compliance with CDISC standards.
Ensure the timely and high-quality delivery of programming outputs for regulatory submissions, clinical study reports, and exploratory analyses.
Ensure all programming activities align with industry standards (CDISC, ICH, FDA, EMA) and internal SOPs.
Programming lead for clinical programs as needed. Hand-on programming work in SAS and other programming languages/tools.
Establishes and maintains CRO/vendor partnerships.
Act as a liaison between statistical programming and other functions, ensuring clear communication and alignment of goals.
Partner with biostatistics, data management, and clinical operations to resolve programming issues and optimize processes.
Identify and implement new tools, techniques, and processes to improve efficiency and quality in statistical programming.

Qualifications:

Master’s degree in statistics, computer science or a related field
At least 8 years of statistical programming experience in the pharmaceutical/biotech industry
Proven ability to manage CRO relationships and oversee programmed deliverables.
Extensive experience in leading statistical programming function for both early and late phase clinical trials, and regulatory submissions (NDA/BLA, MAA)
Excellent skills in SAS programming and statistical reporting, knowledge of R and R Shiny desirable
In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
Familiarity with FDA and ICH regulations and guidelines
Excellent written and verbal communication skills, ability to collaborate with a multidisciplinary team and interact effectively in a fast-paced team environment

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

","hiringOrganization":{"@type":"Organization","name":"MapLight Therapeutics","sameAs":"https://maplightrx.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Burlington, Massachusetts","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":14,"item":{"@type":"JobPosting","title":"Senior Director, Statistical Programming","datePosted":"2025-08-06","description":"

Who We Are

Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.

Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.

What Matters to Us

Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.

Arcellx Core Values

Start with authenticity: We foster an inclusive environment where each person can bring their authentic self to work.

Think ‘we’ before ‘me’: We prioritize collective success, collaborating and supporting one another to achieve our shared goals.

Embrace the challenge: We deliver exceptional results by working with shared determination and a commitment to doing what’s right.

How You’ll Make a Difference

The Senior Director, Statistical Programming, is a key leadership role responsible for overseeing the design, development and delivery of statistical programming solutions across all clinical trials conducted by Arcellx. Your work will have a direct impact on our ability to successfully navigate our trials and get our transformative therapy to patients.

The “Fine Print” – What You’ll Do

Provide oversight development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs.
Review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines.
Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
Oversee and manage work of other programmers.
Develop and/or validate standard macros to automate output production.
Assist with infrastructure development of the department.

Skills and Experience We Look For

BS/BA degree in related discipline.
13+ years of experience in statistical programming with clinical data and SAS.
Experience in oncology therapeutic area preferred.
Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros.
CDISC expertise required.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
Excellent interpersonal communication skills.

Rewards at Arcellx

Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.

The estimated base salary range for this position is $265,000 - $289,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.

Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.

Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com.

#LI-Onsite

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Job Description Summary

Job Description

Lead SP activities for multiple clinical trials within a program or an indication /disease area. Experience in one of the TA areas: Immunology, Cardiovascular & Metabolic Diseases and Neuroscience is must.
Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s).
Responsible for allocating resources within a program and ensuring resource sharing between programs to meet Advanced Quantitative Science and organizational goals.
Recruit, mentor, and nurture statistical programmers. Conduct performance appraisal of direct reports, as applicable.
Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan).
Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training.
Represent SP (Early Development) at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC).

Experience:

In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met.
BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree. Must also be fluent in English
Must have early development experience, ideally in Oncology
Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.
Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions.
Matrix or people management of approximately 6-15 internal or external programmers. Depending on role, may act as a functional/operational manager of associates or may be an individual contributor with no direct reports.
Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs.
At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers. Ideally, 10+ years of industry experience, with at least 6 years in a programming or statistical role. At least 3 years of line management or equivalent leadership experience, such as matrix management (applicable for people managers only).

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? : https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network:

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Programming Languages, Reporting, Statistical Analysis, Waterfall Model","hiringOrganization":{"@type":"Organization","name":"Novartis","sameAs":"https://www.novartis.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"London (The Westworks), United Kingdom","addressCountry":"United Kingdom","addressRegion":"Europe"}}}},{"@type":"ListItem","position":16,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming","datePosted":"2025-08-11","description":"

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Do you have passion for Programming? Do you consider yourself an SME? Would you like to apply your skills to impact the drug development process and regulatory interactions in a company that follows the science and turns ideas into life-enhancing medicines? Then AstraZeneca might be the one for you!

Key Responsibilities:

You will be working in the Oncology Biometrics Programming department reporting to the Director, Statistical Programming, providing leadership and management of statistical programming activities at the project/study level related to the planning, execution and delivery of the statistical programming aspects of clinical development. The scope of work includes, but is not limited to:

Clinical study report development
Regulatory submissions, commercialization, and the scientific utilization of our data for AstraZeneca products
There are many career options you can pursue for progression including technical path, management of global projects or line management.

Essential Education, Experience & Skills:

To succeed in this global role, you need to be an enthusiastic individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You should enjoy multitasking and collaborating with others and have experience with solving problems and resolving conflicts.

Bachelor’s or Master’s (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field
At least 6 years of industry (pharma, CRO) experience with Master's or 8+ years with Bachelor's degree
Diligence – attention to detail and ability to manage concurrent projects and activities
Excellent verbal and written communication skills with an ability to influence stakeholders
Extensive SAS programming expertise to an advanced level within clinical drug development
Comprehensive knowledge of technical and regulatory requirements
Extensive understanding of CDISC standards and industry norms
Experience leading Oncology projects/studies

Desired Education, Experience & Skills:

Strong programming skills related to Oncology Efficacy domains
Experience working/leading global submissions
Leading/Managing a team of programmers both Perm and Contractors

Great People want to Work with us! Find out why:

GTAA Top Employer Award for 10 years

Top 100 Employers Award

Canada’s Most Admired Corporate Culture

Learn more about working with us in Canada

View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

#LI-Hybrid

Date Posted

11-Aug-2025

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

","hiringOrganization":{"@type":"Organization","name":"AstraZeneca","sameAs":"https://www.astrazeneca.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Canada - Mississauga","addressCountry":"Canada","addressRegion":"North America"}}}},{"@type":"ListItem","position":17,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming","datePosted":"2025-08-15","description":"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate Director, Statistical Programming on a permanent basis.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Responsible for the setup and monitoring of the assigned projects.
Managing overall project to ensure the deliverables meets required quality and timeline.
Conduct the meetings with Statisticians and Programmers for business needs.
Manage resources throughout the life cycle of the projects.
Coordinate client activities related to the projects.
Develop and implement standard operating procedures for Programming operation.
Lead or support electronic submission as needed.
Innovative and be able to take initiatives and follow through in Programming workflow optimization.
Hire, train, and mentor statistical Programming staff.

Education and Experience:

Requires a BS or MS degree in computer science, statistics or related field with 4+ years of management experience.
Must be experienced in clinical trial setting.
Excellent problem-solving skills and work independently.

Our Benefits:

Flexible Working Hours
Full performance and development process with end of year reviews
Team events and end of year party
Employee satisfaction survey - your feedback is important for continuous improvement
Health Insurance

The Application Process

Who will you be working for?

","hiringOrganization":{"@type":"Organization","name":"ClinChoice","sameAs":"https://clinchoice.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Yerevan, Armenia","addressCountry":"Armenia","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":18,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming","datePosted":"2025-08-28","description":"

\nAbout Apogee Therapeutics\nFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.\nApogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”\nWe are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. \nIf this sounds like you, keep reading!\n

\nRole Summary\n\n\n

We are seeking an Associate Director of Statistical Programming. In this position you will be responsible for leading statistical programming activities to support various clinical trial projects. You will also support building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution of Apogee’s clinical programs. You will manage programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Key Responsibilities

Serve as a lead statistical programmer on one or more clinical studies
Provide statistical programming oversight to programming vendors
Review and validate datasets and TFLs programmed by vendors
Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
Participate in developing and implementing statistical programming processes and standards.
Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
Build and mentor a team of programmers to support clinical trials and pipelines
Generate ad hoc analyses on ongoing basis

Ideal Candidate

Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry
Advanced SAS programming skills and experience in other statistical software, such as R, etc.
Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
Phase 3 and BLA submissions experience preferred
Excellent organizational skills and ability to prioritize tasks
Excellent communication and interpersonal skills
Experience managing CROs and other data vendors
Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
Ability to keep pace in a fast-moving organization
Advanced knowledge of state-of-art statistical programming methods in clinical study setting
Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
Experience working in a remote virtual environment
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel per business needs (at least 4 – 8 times per year)

The anticipated salary range for candidates for this role will be $185,000-$210,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

\nWhat We Offer \n\n

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Flexible PTO
Two, one-week company-wide shutdowns each year
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

\n\n \nE-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.\n \nApogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.\n \nTo review our privacy policy, click here\n \nIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.\n

","hiringOrganization":{"@type":"Organization","name":"Apogee Therapeutics","sameAs":"https://www.apogeetherapeutics.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote"}}}},{"@type":"ListItem","position":19,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming","datePosted":"2025-08-25","description":"

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary:

The Associate Director, Statistical Programming is accountable for program specific statistical programming activities and oversight related activities by vendors in clinical development, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. In collaboration with cross functional stakeholders, this position contributes to process optimization and innovation for clinical development. This position serves as the program team point person for statistical programing and data standards, provide consultation to the program teams, and be responsible for building a statistical programming team to support the Dyne clinical portfolio. This role assists the Head of Statistical Programming to contribute to departmental strategies and helps to drive the development and continuous improvement of departmental procedures, training, and standards.

Primary Responsibilities Include:

Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines
Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements
Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures, TLFs) in accordance with regulatory guidelines and internal standards
Review statistical analysis plans (SAPs) to provide feedback and strategy to the team to execute the plans
Perform complex statistical analyses and simulations using SAS, and R, to support clinical trial design and data interpretation
Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
Build and maintain software agnostic solutions/macros to automate repetitive tasks.
Provide novel solutions to the Biometrics and cross-functional teams to better understand the data
Mentor and provide guidance to junior programmers, ensuring their growth and development within the team
Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis

Education and Skills Requirements:

Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field
Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotech industry
Proficiency in SAS is essential; experience with Python and R is desirable
Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
Demonstrated leadership and project management skills, including the ability to lead cross-functional teams
Excellent communication and interpersonal skills
Detail-oriented with a commitment to data accuracy and quality
Ability to adapt to changing priorities and manage multiple projects simultaneously

#LI-Onsite

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Statistical Programming for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Job Accountabilities:

Work with a Director, Senior Director, and/or Executive Director of Biostatistics/Biometrics to manage clinical trial programs/projects from one or multiple clients. Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.

Represent the company and the Statistical Programming department in business development and client relationship management initiatives.

Provide leadership and oversight to the assigned client programs/projects; ensure quality, timely, and within budget deliveries.

Follow-up on the industry trends in data and programming standards and good programming working practices. Follow-up on the latest technologies, consult with clients, upper management, peers, and subordinates to evaluate, recommend, and implement improvements to the existing company standards and good working practices.

Develop and maintain clinical data and statistical reporting standards in line with pharmaceutical industry standards and conventions.

Coach, mentor, develop, and provide technical review, advice, and expertise to direct subordinate Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.

Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates by contributing to the performance evaluation process.

When required, serve as a principal level Statistical Programmer, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.

Perform quality control (QC) review of statistical programming deliverables, including documentation, before they are released for production, delivered to clients, or submitted to regulatory agencies. These QC activities may include, but are not limited to, the following:

Review and confirm SDTM dataset specifications. Perform QC activities on SDTM datasets programmed by other Statistical Programmers and Biostatisticians.
Review and confirm ADaM dataset specifications. Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
Perform overall review of statistical tables, listings, and figures (TLFs).
Review and confirm define documents and reviewer’s guides for SDTM and ADaM datasets.

When required, review and provide input to clinical data management deliverables including, but not limited to, the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (Plan; and the ongoing data review TLFs in accordance with the Plan), and Data Management Plan (DMP).

Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Qualifications:

Must have at least a bachelor degree and preferred to have M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with at least 14 years of clinical research experience.

Requires demonstrated experience and success in leading statistical programming teams in planning and implementing statistical programming project plans, leading programming teams to generate and deliver quality and timely deliverables within budget.

Requires demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas.

Requires demonstrated experience supporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses.

Experience with multiple regulatory agencies preferred (FDA, PMDA, etc.).

Experience with developing and delivering training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.) preferred.

Must have an in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.

Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts.

Exceptional written communication and presentation skills.

Travel level specification: This position may require up to 10% business travel.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com.

Estimated Salary Range: $170,000 - $205,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

#LI-Remote | #LI-TK1

#INDHP

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Career Category

Clinical Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Senior Director Global Statistical Programming

What you will do

Let’s do this. Let’s change the world.

Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As Sr. Director of Statistical Programming, you will provide local functional leadership from AIN, supporting global clinical development programs in close partnership with global teams through seamless execution that leverages digital innovation to drive quality deliverables, operational excellence, and regulatory compliance.

Responsibilities:

Provide strategic and operational leadership for statistical programming delivery within Amgen’s global framework, with site accountability based in AIN.
Oversee the execution of statistical programming activities in AIN, ensuring quality, timeliness, compliance, and inspection readiness.
Shape and grow a center of programming excellence at AIN, aligned with Amgen’s global delivery model and standards, including hiring, onboarding, mentoring, and performance management.
Lead the implementation of reusable code frameworks, standardized processes, and scalable programming models to drive quality, speed, and consistency.
Collaborate cross-functionally with Biostatistics, Data Management, and Regulatory Writing to align programming deliverables with strategic timelines.
Champion the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency.
Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building.

This position will be located at Amgen India (Hyderabad).

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.

Basic Qualifications:

BA/BSc or higher degree in biostatistics, statistics, mathematics, or other related quantitative or scientific

subjects

Preferred Skills:

MSc or higher degree in biostatistics, statistics, mathematics, or related quantitative or scientific subjects
Extensive experience with SAS and CDISC standards, and with global regulatory submissions
Demonstrated success managing large teams to complete end to end statistical programming activities from study start up to regulatory submissions
Familiarity with open-source programming tools (e.g. R, Python), automation platforms, and emerging technologies in statistical programming
Experience applying or managing Agentic AI or automated workflows within a GxP environment
Proven ability to drive process innovation, implement standardization strategies, and deliver high-quality outputs across studies
Strong cross-functional collaboration skills and ability to work in a global matrix structure
Excellent communication and leadership skills, with the ability to influence at multiple levels of the organization

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

.","hiringOrganization":{"@type":"Organization","name":"Amgen","sameAs":"https://www.amgen.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"India - Hyderabad","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":22,"item":{"@type":"JobPosting","title":"Statistical programming Internship- HYBRID","datePosted":"2025-09-05","description":"

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our internship team as a Statistical Programmer Analyst Intern on a temporary basis.

Please note this is a temporary position with the opportunity to be considered for a full-time statistical programmer analyst, given successful performance as an intern.

Summary
This is an entry-level Statistical Programmer Analyst Intern-Hybrid position and will involve working with statistical programmers to perform the statistical programming tasks related to basic clinical drug research.

Main Job Tasks and Responsibilities:

Develop SAS programs to create ADAM datasets following CDISC standards with supervision.
Develop SAS programs to create SDTM datasets following CDISC standards with supervision.
Develop, debug, maintain SAS programs and macros to create Tables, Listing and Graphs for Clinical Study Report with Supervision.
Develop SAS programmable edit checks to assist data monitoring, document and report issues to supervisor.
Perform other programming tasks as needed per Supervisor requests.

Education and Experience:

Bachelor/Master’s degree in Mathematics, Statistics, Computer Science/Engineering or related scientific disciplines required.
Knowledge and training in high-level computing languages such as SAS, C/C++, Java, R, Python, MATLAB and SQL.
SAS Base Certification is needed. Database programming experience is a plus.
Detail oriented and ability to learn and adapt to changes.
Good communication skills, both written and verbal and Good team player.
Good working experience in Microsoft Office Suite, e.g., Word, Excel, PowerPoint etc.

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act (\"PIPEDA\") , personal information is collected under the authority of the Act and will only be used for candidate selection.

#LI-TT1 #LI-Hybrid#Junior#internship

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At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

We are seeking an experienced programmer to join us as a Senior Statistical Programming Analyst. This is a critical role responsible for executing statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.

Preferred location: Waltham, MA (onsite or hybrid 2-3 days per week).

Responsibilities:

Develop, validate, and maintain SAS programs for clinical study reports, ad hoc analysis, and integrated safety summary analysis
Oversee and coordinate statistical vendors’ activities to ensure high-quality deliverables: aCRF, data specification and dataset for SDTM and ADaM, mock shell, and TFLs
Conduct independent validation and quality checks of statistical programming deliverables from vendors
Participate in development and QC of integrated safety analysis: data specifications, datasets, and TFL outputs
Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines
Collaborate closely with biostatisticians and cross-functional study teams to deliver results with speed and quality
Communicate proactively and effectively around issues and risks and contribute to its remediation

Required Qualifications:

Minimum of 4+ years of relevant experience
Proven hands-on experience in programming for clinical development with a strong preference for late-phase clinical trial support
Experience in overseeing vendors, including independent validation of datasets and TFLs and other statistical deliverables
Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
In-depth understanding of CDISC standards
Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
Good communication and collaboration skills in a cross-functional team environment

Preferred Qualifications:

A background in cardiometabolic diseases or related therapeutic areas is preferred

Education:

MS in Biostatistics, Statistics, or a related field

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range$110,000—$140,000 USD

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

#LI-Hybrid

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The Lead Biostatistician builds and maintains trusted advisor relationships with clients and internal teams, focusing on delivering client value and fostering long-term growth. They are responsible for developing and leading high-performing project teams, ensuring all work is conducted in compliance with internal SOPs, ICH guidelines, industry standards, and regulatory requirements.

Key responsibilities include reviewing and approving all biostatistics documentation and statistical programming outputs, overseeing project budgets and timelines, and ensuring overall quality and consistency across assigned accounts.

In addition, the Lead Biostatistician contributes to talent acquisition efforts and collaborates with Quality Management to establish and maintain standard operating procedures (SOPs) and training programs. They provide advanced statistical expertise in the planning and design of clinical trials and non-interventional studies (NIS), perform in-depth data analyses, and offer statistical guidance for study reporting.

What you will do:

Provide strategic statistical guidance on study design, including statistical model selection, sample size calculations, and analysis planning across clinical trials and non-interventional studies (NIS).
Lead the development and programming of statistical analyses, tables, figures, and listings (TFLs) using SAS, ensuring alignment with sponsor requirements and internal standards.
Generate and validate derived analysis datasets in compliance with CDISC ADaM standards.
Author, review, and ensure rigorous quality control (QC) of Statistical Analysis Plans (SAPs) and related statistical documentation.
Validate programming output (e.g., TFLs, datasets) generated by team members to ensure accuracy and consistency.
Provide expert statistical input to study documents, including Case Report Forms (CRFs), Data Management Plans (DMPs), and clinical protocols.
Oversee and ensure proper execution of randomization procedures.
Conduct and interpret meta-analyses using statistical results from multiple published studies, ensuring scientifically robust conclusions.
Lead the statistical review and interpretation of Clinical Study Reports (CSRs), ensuring alignment with the SAP and regulatory expectations.
Proactively prioritize and manage multiple studies and projects to meet timelines and client expectations, balancing resources and risk.
Serve as a primary statistical point of contact for internal and external stakeholders, providing clear, compliant, and insightful responses and guidance.
Ensure all statistical deliverables meet applicable regulatory standards (e.g., ICH, GCP), industry guidelines, and internal SOPs.
Foster and maintain trusted relationships with clients, leading communication on statistical matters and contributing to long-term collaboration.
Drive the continuous improvement and development of internal statistical programming practices, guidelines, and SOPs.
Mentor junior team members, contribute to training initiatives, and promote a high-performing, quality-focused team culture.
Serve as a domain expert, integrating clinical, statistical, and industry best practices to design tailored solutions for complex client needs.
Collaborate with cross-functional teams to deliver innovative, high-impact statistical strategies that align with client objectives.

Requirements:

Education

Master’s degree in Statistics, Biostatistics, or a related quantitative field is requiredwith a minimum of 5-8 of practical experience.
PhD in a relevant field is highly preferred.

Experience

Minimum 5–8 years of relevant experience in biostatistics, preferably in the pharmaceutical, CRO, or life sciences sector.
Solid experience with non-interventional / observational studies and Phase 3 or Phase 4 clinical trials.
Demonstrated experience working with CDISC standards (including SDTM and ADaM).
Good knowledge of the industrial standards (CDISC, ICH E9, GCP)
Proficiency in SAS and R programming with a minimum of 5 years of experience with both software.
Prior experience acting as a client-facing lead statistician, including proposal support and study design.
Strong understanding of project management, including budget management, timelines, and resource allocation.
Experience mentoring or leading junior statisticians or project team members.
Ability to further develop programming standards and research methods

Skills

Excellent communication skills (written and verbal) in English.
Ability to manage multiple studies and clients simultaneously.
Strong organizational skills and attention to detail.
High level of initiative, accountability, and professionalism.
Excellent skills and knowledge of MS Office and IT
Sound numerical reasoning
Highly analytical with a problem-solving approach

Career Level - IC4

As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.

We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling +1 888 404 2494 in the United States.

Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
As the Senior Manager, Statistical Programming, you will be responsible for leading Statistical Programming efforts at REGENXBIO which includes primary and/or validation programming for assigned clinical trials. Additionally, your responsibilities can include the assigning and tracking of work for more junior programmers.\n

What You'll Be Doing

Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects
Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirements, and statistical instructions
Develops and/or validates SAS programs to generate statistical output (e.g. TLFs) of clinical trial data as specified in the Statistical Analysis Plan (SAP), as required for regulatory and safety review reasons (i.e. DSUR or IDMC deliverables), and for ad hoc analysis as requested
Documents data and programming information in accordance with SOPs, guidelines and industry standards
Manages timelines for statistical programming activities
Assists the Head of Statistical Programming in developing templates for derived dataset specifications, programming specifications, and other supporting documents
Develops SAS macros, templates and utilities for reporting and data cleaning
Oversees and manages Contract Research Organizations (CROs)
Develops and tests SAS codes for clinical trial database logic checks
Assign tasks to and monitor timelines for junior programmers
It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

Bachelor’s Degree in Computer Science, Statistics, Mathematics, or a related scientific discipline required
Minimum 8 years of experience in statistical programming in a clinical trial environment
SAS programming at an expert level
Understanding of the drug development process and the functions and roles in a Pharmaceutical/Biotech clinical organization
Excellent knowledge of regulatory requirements as related to statistical programming (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.)
Excellent knowledge of concepts related to statistical programming (e.g., coding dictionaries, annual reporting, EDC systems, etc.)
Outstanding verbal and written communication skills
Ability to effectively project manage and assign tasks to other programmers
Ability to build successful relationships and interact at the project team level

Why should you apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company, with an incredible team, who is passionate about developing novel AAV gene therapies for patients in need.
We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more! The estimated compensation range for this role is $140,000 to $193,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.
In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally.
","hiringOrganization":{"@type":"Organization","name":"REGENXBIO","sameAs":"https://www.regenxbio.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Rockville, Maryland","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":26,"item":{"@type":"JobPosting","title":"Senior Manager, Statistical Programming - Oncology Early Development","datePosted":"2025-08-26","description":"

Company Description

Job Description

Purpose-

Responsibilities-

Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff.
Participates in the recruitment and selection of new staff.

Qualifications

MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Minimum of 2 years experience leading a team of statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.

Key Stakeholders

• Directors of Statistics
\n• Data Scientists
\n• Medical Writers
\n• Regulatory Publishers
\n• Clinical Project Managers

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

","hiringOrganization":{"@type":"Organization","name":"AbbVie","sameAs":"https://www.abbvie.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Chicago, IL, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":27,"item":{"@type":"JobPosting","title":"Senior Manager, Statistical Programming - Oncology Early Development","datePosted":"2025-08-26","description":"

Company Description

Job Description

Purpose

Responsibilities

Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff.
Participates in the recruitment and selection of new staff.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Minimum of 2 years experience leading a team of statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.

Key Stakeholders

• Directors of Statistics
\n• Data Scientists
\n• Medical Writers
\n• Regulatory Publishers
\n• Clinical Project Managers

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

","hiringOrganization":{"@type":"Organization","name":"AbbVie","sameAs":"https://www.abbvie.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"South San Francisco, CA, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":28,"item":{"@type":"JobPosting","title":"Senior I Statistical Programming Lead","datePosted":"2025-07-15","description":"

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India

Job Description:

Job Description

Position Summary

The Senior Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of low-medium complexity/criticality.

The Senior Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams.

As an experienced Statistical Programmer this position applies advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams. In addition, the Senior Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects.

Principal Responsibilities

As a Programming Lead;

Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality.
Coordinates and supervises programming team activities and provides technical and project specific mentorship to programming team members to ensure quality and timely statistical programming deliverables in compliance with departmental processes and procedures.
Develops detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission.
Performs comprehensive review of, and provides input into, project requirements and documentation.
Collaborates optimally with statistical programming and cross-functional team members and counterparts to achieve project goals.
As applicable, coordinates statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.

As an experienced Statistical Programmer;

Designs and develops programs in support of sophisticated clinical data analysis and reporting activities.
Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality.
May contribute to or lead others in an area of expertise that results in solutions growing the efficiency and quality of deliverables across multiple projects.
May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams.
Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.
May contribute to departmental innovation and process improvement projects.

Principal Relationships

Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities.
Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing.
Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary interfaces within clinical project (trial), program, and submission teams.
External contacts include but are not limited to external partners including CROs.

Qualifications - External

Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 6-8 years programming experience with growing responsibility, preferably in a pharmaceutical/clinical trial environment.
Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures.
Proven experience planning and coordinating programming activities and leading teams.
Proven experience working with cross functional stakeholder and teams.
Solid understanding of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.
Basic project management skills.
Demonstrated written and verbal communication skills.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

","hiringOrganization":{"@type":"Organization","name":"Johnson & Johnson","sameAs":"https://www.jnj.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"IN022 Hyderabad, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":29,"item":{"@type":"JobPosting","title":"Associate Manager - Statistical Programming-1","datePosted":"2025-08-18","description":"

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Functions, Duties, Tasks:

Use SAS or other software to develop custom programming code to generate tables, data listings, graphs and derived datasets as specified in the protocol/statistical analysis plan.
Ensure that outputs meet quality standards and project requirements.
Perform validation programming and work with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
Keep project team members informed of programming progress and issues requiring their attention.
Follow applicable SOPs and relevant regulatory guidelines.
Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and complete project programming activities within timeframe allotted.
Assist in drafting regulatory submissions.
Effectively utilize current technologies and available tools for conducting the analyses.
Ensure scientific integrity and animal welfare in all activities.
Interact with global statisticians and implement recommendations locally.
Create and maintain standard macros and applications to improve the efficiency of the department.
Proactively participate in and/or lead process/quality improvement initiatives, standardization and other non-clinical initiatives.
Develop wider knowledge of SAS and other relevant programming languages and processes within the GO, Biostatistics and Medical arenas.

Engage in knowledge share activities.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Elanco (NYSE: ELAN) – it all starts with animals!

Making animals’ lives better makes life better – join our team today!

Functions, Duties, Tasks:

Use SAS or other software to develop custom programming code to generate tables, data listings, graphs and derived datasets as specified in the protocol/statistical analysis plan.
Ensure that outputs meet quality standards and project requirements.
Perform validation programming and work with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
Keep project team members informed of programming progress and issues requiring their attention.
Follow applicable SOPs and relevant regulatory guidelines.
Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and complete project programming activities within timeframe allotted.
Assist in drafting regulatory submissions.
Effectively utilize current technologies and available tools for conducting the analyses.
Ensure scientific integrity and animal welfare in all activities.
Interact with global statisticians and implement recommendations locally.
Create and maintain standard macros and applications to improve the efficiency of the department.
Proactively participate in and/or lead process/quality improvement initiatives, standardization and other non-clinical initiatives.
Develop wider knowledge of SAS and other relevant programming languages and processes within the GO, Biostatistics and Medical arenas.

Engage in knowledge share activities.

","hiringOrganization":{"@type":"Organization","name":"Elanco","sameAs":"https://www.elanco.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"IN - Bangalore, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":31,"item":{"@type":"JobPosting","title":"Senior Data Analyst (Statistical Programming)","datePosted":"2025-08-26","description":"Senior Data Analyst (Statistical Programming)
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!
About the RoleCelerion is seeking a Senior SAS Data Analyst to join our Data Management and Biometrics team in Belfast, Northern Ireland to provide statistical programming support for early-phase clinical research. In this role, you will independently design, develop, maintain SAS programs to support the analysis and reporting of clinical trial data.
The Primary Responsibilities of this Position Are:- Independently develop, maintain, and process SAS programs for clinical studies, creating analysis data packages (ADaM), statistical analyses, data listings, tables, and figures.- Perform peer QC, double programming and validation functions for statistical outputs from studies.- Lead statistical programming activities on studies and deliverables. - Assist Management and Biostatisticians with complex projects.- Design and implement SAS programs for standardized use.- Train and mentor junior programmers.- Ensure compliance with statistical analysis plan and departmental procedures.
\n

Requirements

Minimum of a Bachelor’s Degree in Statistics, Mathematical Science, Physics, or Computing related field.
4+ years of SAS® programming experience in a CRO or Pharmaceutical industry.
Proficient in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/ODS.
Experience applying CDISC requirements to generate ADaM datasets and supporting documentation (define.xml, Reviewer’s Guides), demonstrating proficiency in these areas.
Excellent interpersonal skills.
Strong problem-solving and decision-making abilities.
Demonstrates a high level of attention to detail.
Demonstrated ability to work collaboratively as part of a team.
Familiarity with R, Python, and other programming languages preferred.

Celerion are an equal opportunities employer","hiringOrganization":{"@type":"Organization","name":"Celerion","sameAs":"https://www.celerion.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Belfast, Northern Ireland","addressCountry":"United Kingdom","addressRegion":"Europe"}}}},{"@type":"ListItem","position":32,"item":{"@type":"JobPosting","title":"Associate Principal Scientist, Statistical Programming","datePosted":"2025-09-02","description":"

Job Description

Position description:

Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.
Develop and execute statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
Design and maintain statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
Act as a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.
Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance.
Responsible for effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model.
Maintain and manage a project plan including resource forecasting. Coordinate the activities of a global programming team that includes outsource provider staff.
Serve as a member on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.

Education requirements:

Must have a Bachelor’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Biological Sciences, Engineering or closely related field plus 9 years SAS programming experience in a clinical trial environment
OR a Master’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Biological Sciences, Engineering or closely related field plus 7 years SAS programming experience in a clinical trial environment.

Requirements:

Experience and knowledge in leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.
Must possess broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements.
Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and systems and database expertise;
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
Must possess ability to determine appropriate programming methodology, assure programming consistency across protocols and projects, complete programming tasks, and direct the program development effort of other programmers
Ability to engage key stakeholders;
Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts; design and develop complex programming algorithms.
Ability to anticipate stakeholder and regulatory requirements.
Must be an experienced programming mentor; and a program leader.
Must possess familiarity with statistical analysis methods and clinical data management concepts; strong project management skills;
Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilate to new projects and stakeholders.
Must possess strategic thinking - ability to turn strategy into tactical activities; ability to design statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

The salary range for this role is

$139,600.00 to $219,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at Compensation and Benefits Webpage.

You can apply for this role through the Career Site (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

N/A

Required Skills:

Preferred Skills:

Job Posting End Date:

11/16/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

Beam is seeking a highly talented and motivated Statistical Programming, Biometrics Co-op to join our Biometrics team from January through June 2026. The co-op will learn to provide statistical programming support for clinical studies, learn to program CDISC datasets (SDTM/ADaM) and report the statistical summary results with tables, listings and figures. They will perform validation of datasets and tables, figures, as well as other supporting activities for the Statistical Programming group (for example, data visualization, patient profile and enhancement of existing data analysis tools). The candidate is expected to implement SAS programming methods in R and generate datasets (SDTM/ADaM) in R/Python.

Responsibilities:

Develop, review, and validate SAS programs to generate datasets, tables, figures and listings.
Develop programs to generate tables and figures in R/Python.
Support implementation of tools to facilitate the data visualization and patient profiles in R/Python.
Support implementation of data exploration analysis in R/Python.
Understand company SOPs and relevant industry’s standards.
Enhance existing data analysis macro tools.
Prepare a final presentation for the Statistical Programming group.

Qualifications:

Currently pursuing a BS or MS in Statistics, Mathematics, Computer Science, or Engineering.
Knowledge of R/R-Shiny or Python is preferred.
Knowledge of SAS language, procedures, and options for clinical trial data and reporting including BASE SAS, Macro language, SAS/STAT and SAS/Graph is preferred.
Proficient in Adobe Acrobat for annotating documents and creating consolidated files.
Strong written, verbal, and interpersonal communication skills.
Ability to work collaboratively as part of a team.
Must be able to work onsite, not a remote role.
Applicants must be currently enrolled in a degree-granting college or university program and maintain their student status throughout the duration of the co-op to be eligible.

","hiringOrganization":{"@type":"Organization","name":"Beam Therapeutics","sameAs":"https://beamtx.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Cambridge, MA","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":34,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming - R Implementation","datePosted":"2025-07-16","description":"

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary:

The purpose of this job is to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and R shiny app development. Lead the R programming implementations. Represent programming in DS external collaborations on R technology and capabilities.

Responsibilities:

- Lead/contribute to DS R programming system technology development: Lead/contribute to the R programming system development. Act as R programming SME and functional representative of R systems and infrastructure to identify system and technology development needs and to define functional requirements. Provide technical guidance to the development. Lead and may approve UATs. Lead/contribute to resolutions of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties. Lead the trainings and implementations of R system and programming technology.
- Developing R package and Shiny apps: Contribute to strategy of R programming innovation to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the development and validations of R package and/or shiny apps. Identify and build the use cases and process/resources to guide the implementations. Lead, advocate and nurture R programming innovation globally within DS. Represent the programming innovation outside of DS and establish the company reputations and images.
- Develop study specific shiny apps or execute shiny apps at study level. Publish shiny apps for study or against integrated database
- Representing cross-functional collaborations on R capabilities and systems: Collaborate with RD non-BDM and non-RD R user group or developers. Collaborate with biostat innovation to enhance BDM overall R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (i.e., ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

- Bachelor's Degree an accredited institution in a science or in a technical field such as computer science or mathematics required
- Master's Degree preferred Experience Qualifications

- 10 or More Years Bachelor’s degree with minimum 10 years (or Master’s degree with minimum of 7 years) proven experience required
- 7 or More Years Previous experiences in R programming area, involved in R and/or Shiny app development and implementation. required
- Advanced working knowledge of all aspects of the R and SAS programming language used in clinical trials programming. required
- Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis required
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. required
- Having knowledge of all phases of drug development, including early and late phase clinical development and submission required
- Having solid background of applied statistics required
- Solid knowledge of new advanced statistical methods using SAS or R required
- Advanced knowledge in database structures and set-up required

Travel: Ability to travel up to 10%

Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range:

$168,000.00 - $252,000.00

Download Our Benefits Summary PDF

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Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Head of Biostatistics & Statistical Programming is responsible for the statistical aspects within the Global Development organization including clinical trials, experimental design, statistical analysis and reporting. This experienced and innovative biostatistician will work collaboratively with clinicians, regulatory leads, clinical operations, data managers, and biostatisticians in the planning and analysis of clinical studies and disease monitoring programs. This position will oversee Biostatistics/Epidemiology and Statistical Programming groups and will provide overall leadership to this team. Reporting to the CMO, this role will sit on the CMO’s leadership team and play a critical role in the biostatistical strategic planning for all clinical programs at the company.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

Lead the Biostatistics/Epidemiology and Statistical Programming teams
Ensure statistical integrity of clinical studies conducted to support projects across the portfolio
Set strategy for the department, including enhancing technical expertise in support of drug development and enabling development of staff
Build/drive relationships and teamwork across the Biostatistics and Programming teams in support of the programs ensuring proper statistical strategies, and understanding of priorities between the project teams and the teams
Provide statistically/epidemiologically sound scientific methodology leadership in experimental design and data analyses
Review statistical analysis sections of protocols, statistical analysis plans, study reports, regulatory documents or scientific publications, generates/reviews study sample size/power estimations
Provide leadership in the interpretation and reporting of the results of statistical analyses.
Mentor lead statisticians/epidemiologists in presenting the statistical concepts, evidence, interpretations, and logical arguments to the project team and senior management
Independently pursue analyses suggested by the data; Propose new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results
Contribute to the advancement of research in clinical trials methodology. Establish a healthy culture in the department, including collaboration and quality mindset
Develop and evaluate options for meeting project team goals under time and budgetary constraints and can change course quickly

Requirements:

Ph.D. in Applied Statistics, Statistics, or Biostatistics
15+ years of experience applying statistics and epidemiology methods in a biopharmaceutical industry
Demonstrated statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, analysis of clinical imaging results such as X-Ray
Experience in designs and Bayesian data analyses, rare disease global clinical development and applying epidemiological methodology to support delivering rare disease therapies for patients
Has influenced external environment through contributions to presentations, and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical and epidemiological methodologies
Experience in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
Experience with regulatory guidance and guidelines, and general knowledge of industry best practices. Expert knowledge in Health Authority interactions and submission strategies, IND/BLA/NDA/MAA submissions, and writing technical and management documents

#LI-CS1 #LI-Remote

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$307,100—$379,400 USD \nFull Time employees across the globe enjoy a range of benefits, including, but not limited to:\n \n· Generous vacation time and public holidays observed by the company\n· Volunteer days\n· Long term incentive and Employee stock purchase plans or equivalent offerings\n· Employee wellbeing benefits\n· Fitness reimbursement\n· Tuition sponsoring\n· Professional development plans\n \n* Benefits vary by region and country\n\n

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

\n\nSee our CCPA Employee and Applicant Privacy Notice.\nSee our Privacy Policy.\n\n

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

\n\nNote to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.","hiringOrganization":{"@type":"Organization","name":"Ultragenyx","sameAs":"https://www.ultragenyx.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"United States - Remote","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":36,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming - R Implementation","datePosted":"2025-08-28","description":"

Join a Legacy of Innovation 125 Years and Counting!

Summary:

Travel: Ability to travel up to 10%

Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

Salary Range:

$168,000.00 - $252,000.00

Download Our Benefits Summary PDF

Job Description

Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.

This position supports statistical programming analysis and reporting activities for Health Technology Assessment (HTA) dossiers.

In this role, the senior statistical programmer will support the development of scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives. The senior statistical programmer contributes to the definition and implementation of strategic solutions utilizing SAS and R programming to create analysis datasets, tables, listing and figures from clinical trial data. The senior statistical programmer is a key collaborator with HTA statisticians and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. For assigned projects, the position serves as the statistical programming point of contact and knowledge holder. The senior statistical programmer may lead and mentor the statistical programming project team members as well as perform direct programming and validation activities following departmental SOPs.

Responsibilities:

Programmatically develop, validate and maintain analysis and reporting deliverables for HTA dossiers.
Ensure proper project planning; provide statistical programming project leadership to key project dimensions.
Assure deliverable quality and compliance with departmental SOPs and good programming practices.
Collaborate effectively with project team members; be a valued part of project teams.
Membership on departmental strategic initiative teams.

Your Profile:

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 5-9 years programming experience in programming languages like SAS and/or R.

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 3-7 year in SAS and/or R programming experience.

Department Required Skills and Experience:

Effective interpersonal skills and ability to negotiate and collaborate effectively.
Effective English written, oral, and presentation skills.
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders.

Position Specific Required Skills and Experience:

Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
Ability to learn new program techniques and data structures quickly and effectively; capacity to seamlessly assimilate to new projects.
Basic understanding of statistics, clinical and data management concepts as applied to drug/vaccine development within the pharmaceutical industry.
Ability to comprehend analysis plans which may describe HTA research and statistical programming methodology to be programmed; an understanding of statistical terminology and concepts.
An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility.
Knowledge in CDISC SDTM and ADaM standards.
Designs and develops complex programming algorithms.
Experience ensuring process compliance and deliverable quality.
Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.
Ability to anticipate stakeholder requirements.
Team oriented with demonstrated history of teamwork and collaboration, enjoying diversity, respect and integrity.

Preferred Skills and Experience:

Experience in supporting analysis and reporting deliverables for HTA dossiers.
Unix operating system experience; Oracle SQL experience; systems and database experience.
Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC).
Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor.
Experience developing and managing a project plan using Microsoft Project or similar package.
Ability and interest to work across cultures and geographies.
Active in professional societies.
Experience in process improvement.

THE COMPANY

Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office is staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

N/A

Required Skills:

Clinical Information Systems, Clinical Testing, Computer Science, Data Management, Data Modeling, Health Technology Assessment (HTA), Microsoft Project, Numerical Analysis, Project Management, Science, Software Development, Statistical Analysis Software (SAS), Statistical Programming, Teamwork, Waterfall Model

Preferred Skills:

Clinical Trials, Statistics

Job Posting End Date:

08/29/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India

Job Description:

Position Summary:

The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures.
As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers.

The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality.

In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams.
In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects.

Principal Responsibilities:
• Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests.
• Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
• Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities.
• Performs comprehensive review of, and provides input into, project requirements and documentation.
• Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations.
• As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
• Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads.

• Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert.
• Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position.

Clinical Programming:
• Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.
• Responsible for implementation of data tabulation standards.
• Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring.

Statistical Programming:
• Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program.

Principal Relationships:

The Principal Programming Lead reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities.
• Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.
• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources.
• External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups.

Education and Experience Requirements:
Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD).

Experience and Skills Required:
• Approx. 12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. Experience in early development/clinical pharmacology studies (BA/BE, DDI, FE etc.) will be preferable.
• In-depth knowledge of programming practices (including tools and processes).
• Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11)
• Project, risk, and team management and an established track record leading teams to successful outcomes.
• Excellent planning and coordination of project delivery.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.

• Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments.
• Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience.
• Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g., working with CROs, academic institutions) is preferred.
• Expert CDISC Standards knowledge.
• Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role.
• Excellent written and verbal communications and influencing and negotiation skills.
• Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts.

Other:
• Innovative thinking allows for optimal design and execution of programming development strategies.
• Development and implementation of a business change/innovative way of working.

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Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all therapeutic areas. The senior programmer will gather and interpret user requirements, retrieve the required data, transform the data into modeling-ready analysis datasets, and develop tables and figures according to the modeling analysis plans. The programmer will take on a data stewardship leadership role and be accountable for the creation of modeling data from original data source(s) to final modeling dataset. The programmer will be a key collaborator with modelers, statisticians and other project stakeholders.

Primary Activities:

Programmatically synthesize preclinical data into analysis ready structures from varied data sources
Create modeling-ready datasets by integrating PK, PD and covariate data
Produce tables and graphics for inclusion in study reports and regulatory submissions
Ensure programmatic traceability from data source to modeling result
Support the development of programming standards to enable efficient and high-quality production of programming deliverables
Produce SAS transport files and associated documentation for regulatory submissions

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

Effective interpersonal skills and ability to negotiate and collaborate effectively
Effective written, oral, and presentation skills
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

Position Specific Required Skills and Experience:

Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical or pharmacokinetic terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements, knowledge of pharmaceutical development processes
Efficiently manipulates clinical trial datasets including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).

Preferred Skills and Experience:

Familiarity with pharmacokinetics modeling and simulation datasets and analyses
Experience with at least one other software than SAS (e.g., R, Splus, NonMem)
Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Utilizes and contributes to the development of standard departmental SAS macros
Ability and interest to work across cultures and geographies
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Active in professional societies
Oncology experience is a plus

SPjobs

BARDS2020

#VETJOBS

eligibleforERP

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

EEOC Know Your Rights

EEOC GINA Supplement

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

The salary range for this role is

$114,700.00 - $180,500.00

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Business, Clinical Site Management, Clinical Testing, Communication, Data Management, Data Modeling, Global Sourcing, Mechatronics, Numerical Analysis, Outsourcing, Pharmaceutical Development, Pharmacokinetics, PKPD Modeling, Site Initiation, Social Collaboration, Software Development, Stakeholder Engagement, Stakeholder Relationship Management, Statistical Programming, Waterfall Model

Preferred Skills:

Job Posting End Date:

09/12/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

","hiringOrganization":{"@type":"Organization","name":"MSD","sameAs":"https://www.msd.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"USA - Pennsylvania - North Wales (Upper Gwynedd), United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":40,"item":{"@type":"JobPosting","title":"Associate Director, Statistical Programming & Analysis - Oncology Early Development","datePosted":"2025-08-12","description":"

Company Description

Job Description

The Associate Director, Statistical Programming leads the whole stat programming team within CDOR (Clinical Data Operation and Reporting) in OED (Oncology Early Development) clinical development organization. The stat programming team performs statistical programming and analysis oversight for OED all clinical projects conducted by CROs. The associate Director leads the recruitment and training of new staff onboarding activities, manage the overall resource allocation and monitoring on regular basis, provide technical guidance for team members, performs ongoing and annual performance management and staff career development, initiate and lead stat programming related process improvement collaborating with CRO partners, create a collaborative team work environment for both internal staff as well as with CRO partners, build strong relationship with internal and external stakeholders management. This person may also need to support clinical projects if needed, therefore strong hands on stat programming skills for both analysis datasets and TLFs in oncology therapeutics are fundamental to the success of this role.

Responsibilities:

•SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations. Standards: Oversees effort to determine and implement global company standards related to output design and programming conventions. Responsible for monitoring regulatory guidance and industry best practices.
\n•Case report forms and database definitions: Provides strategic guidance on the development of CRFs and database designs. Provides in-depth critical review of global standards related to CRF designs and database designs. Derivation Programming, Submission Data Sets and Programs: Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications. Oversees effort to determine and implement global company standards related to derive data sets and subm
\n•Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas. Demonstrates an understanding of drug development principles. Anticipates potential problems within and across projects and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels. Participates in and is viewed as a key contributor to cross functional initiatives.
\n•Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists. Effectively presents information through planning and execution of meetings and presentations.
\n•Training and Mentoring: Provides appropriate background and motivation to staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures that self and staff are compliant with training requirements. Effectively mentors statistical programming staff with regard to functional operations.
\n•Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects. Works collaboratively with the statistical programming management team to assess project resource requirements versus current staff
\n•Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views. Provide all performance management activities for 4-10 statistical programmers

Qualifications

MS in Statistics, Computer Science or a related field with 10+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 12+ years of relevant experience.
High degree of technical competence and communication ability, both oral and written. Highly competent in SAS programming and Macro
\ndevelopment.
Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and relevant regulatory requirements.
Previous management experience preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

","hiringOrganization":{"@type":"Organization","name":"AbbVie","sameAs":"https://www.abbvie.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"South San Francisco, CA, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":41,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-07-21","description":"

Job Title

Senior Manager

Job Description Summary

Job Description

INCO: “Cushman & Wakefield”","hiringOrganization":{"@type":"Organization","name":"Cushman & Wakefield","sameAs":"https://www.cushmanwakefield.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bengaluru, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":42,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-07-21","description":"

About the Role:

Grade Level (for internal use):

The Team:
The Transactions team’s mission is to produce the most actionable, transparent, trusted, and comprehensive data and insights in the marketplace for critical corporate events like Mergers & Acquisitions, Public Offerings, Investor Activism, Equity Buybacks, and Bankruptcies.

The Role:
We seek a dynamic and strategic Senior Manager to lead a global data operations team responsible for collecting in-depth insights on the M&A dataset within the Transactions data operations. This leadership position is pivotal in ensuring both the integrity of our data assets and exceptional client satisfaction. You will be directly leading a group of frontline managers + data specialists and will be expected to bring a unique blend of operational rigor, talent engagement, and a commitment to continuous improvement.

The Impact:
This role involves leading a group of frontline managers + data specialists, and the candidate is expected to bring a unique blend of operational rigor, talent engagement, and a commitment to continuous improvement. It also warrants other leaders within Transactions and teams within the domain/cluster/content organization to drive various projects and initiatives to deliver best-in-class, differentiated content to meet and exceed client expectations.

What’s in it for you:
This is an opportunity to manage leaders and/or individual contributors and contribute towards achieving the business results. Accountability would be towards understanding and owning the business objectives; be a role model for people and peer groups; communicate with passion and enthusiasm, embrace change as a way of working; and lead by example when communicating new initiatives.

Responsibilities:
•   Manage multiple teams working on collection/value-added tasks within Transactions.
•   Lead teams across assigned business/region for workflow systems with a focus on managing process, productivity, and functionality improvements.
•   Effective coordination and constructive relationships within internal, intra-cluster, and other verticals across EDO.
•   May interact with internal and external clients as necessary, and occasionally work on new projects and data enhancement initiatives as assigned.
•   Own the performance measurement processes, talent development, team engagement, and VIBE for respective teams.
•   Generate and timely share status reports/updates to relevant stakeholders.
•   Manage/support multiple operational or project/focused teams across offices in the planning and implementation of process and operational changes across different teams.
•   Proven ambassador of innovative culture and promoter of transformation via effective usage of AI, Automation, LEAN, etc.
•   Identify individual strengths to appropriately delegate work amongst the team. Guide and coach leads & teams for future growth.

What we’re looking for:
Functional and Business Knowledge:
•   A sound understanding of Transaction dataset processes like M&A, Public Offerings, Private Placements, and understanding of various internal processes.
•   Excellent oral and written communication skills.
•   Strong analytical skills and out-of-the-box thinking.
•   Proven experience in driving strategic/transformation initiatives.

Stakeholder Management and Problem Solving:
•   Ensure cross-functional collaboration (across Data Excellence & Partnership, Product, Technology, etc.) for a timely and successful delivery of strategic projects.
•   Solve a variety of problems within their operational setting.
•   Provide solutions based on best practices and existing precedents.

Experience

7-10 years of relevant experience

Basic Qualifications:
•   Excellent leadership skills and people management skills.
•   Ability to prioritize and manage multiple projects simultaneously.
•   Proven ability to work with minimal direction, maintain focus while working with routine tasks.
•   Strong in Time Management & Presentation Skills

What’s In It For You?

Our Purpose:

Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technology–the right combination can unlock possibility and change the world.

Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence®, pinpointing risks and opening possibilities. We Accelerate Progress.

Our People:

We're more than 35,000 strong worldwide—so we're able to understand nuances while having a broad perspective. Our team is driven by curiosity and a shared belief that Essential Intelligence can help build a more prosperous future for us all.

From finding new ways to measure sustainability to analyzing energy transition across the supply chain to building workflow solutions that make it easy to tap into insight and apply it. We are changing the way people see things and empowering them to make an impact on the world we live in. We’re committed to a more equitable future and to helping our customers find new, sustainable ways of doing business. We’re constantly seeking new solutions that have progress in mind. Join us and help create the critical insights that truly make a difference.

Our Values:

Integrity, Discovery, Partnership

At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals.

Benefits:

We take care of you, so you can take care of business. We care about our people. That’s why we provide everything you—and your career—need to thrive at S&P Global.

Our benefits include:

Health & Wellness: Health care coverage designed for the mind and body.
Flexible Downtime: Generous time off helps keep you energized for your time on.
Continuous Learning: Access a wealth of resources to grow your career and learn valuable new skills.
Invest in Your Future: Secure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs.
Family Friendly Perks: It’s not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families.
Beyond the Basics: From retail discounts to referral incentive awards—small perks can make a big difference.

For more information on benefits by country visit: https://spgbenefits.com/benefit-summaries

Global Hiring and Opportunity at S&P Global:

At S&P Global, we are committed to fostering a connected and engaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets.

Recruitment Fraud Alert:

If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, “pre-employment training” or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here.

-----------------------------------------------------------

Equal Opportunity Employer

S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment.

If you need an accommodation during the application process due to a disability, please send an email to: EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. 

US Candidates Only: The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

-----------------------------------------------------------

10 - Officials or Managers (EEO-2 Job Categories-United States of America), DTMGOP103.2 - Middle Management Tier II (EEO Job Group), SWP Priority – Ratings - (Strategic Workforce Planning)","hiringOrganization":{"@type":"Organization","name":"S&P Global","sameAs":"https://www.spglobal.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"IN - HYDERABAD SKYVIEW, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":43,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-07-21","description":"

Line of Service

Tax

Industry/Sector

Not Applicable

Specialism

Deals

Management Level

Senior Manager

Job Description & Summary

Education (if blank, degree and/or field of study not specified)

Degrees/Field of Study required:

Degrees/Field of Study preferred:

Certifications (if blank, certifications not specified)

Required Skills

Optional Skills

Accepting Feedback, Accepting Feedback, Active Listening, Analytical Thinking, Coaching and Feedback, Communication, Creativity, Domestic Restructuring (Taxes), Embracing Change, Emotional Regulation, Empathy, Inclusion, Income Tax Provisions, Influence, Intellectual Curiosity, Learning Agility, Optimism, Partnership Tax, Professional Courage, Rapid Experimentation, Relationship Building, Retail and Consumer (Taxes), Self-Awareness, Service Excellence, Storytelling {+ 12 more}

Desired Languages (If blank, desired languages not specified)

Travel Requirements

Not Specified

Available for Work Visa Sponsorship?

Government Clearance Required?

Job Posting End Date

","hiringOrganization":{"@type":"Organization","name":"PwC","sameAs":"https://www.pwc.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Melbourne, Australia","addressCountry":"Australia","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":44,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-08-04","description":"

Skill (Primary)

Customer Experience Platform-Adobe-Adobe Experience Manager ( AEM)

Location

Noida

Job Family

Development

Job Description (Posting).

About HCLTech
HCLTech is a global technology company, spread across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. We re powered by our people a global, diverse, multi-generational talent - representing 161 nationalities whose unique spark, perspective and boundless passion drive our culture of proactive value creation and problem-solving.
Our purpose is to bring together the best of technology and our people to supercharge progress for everyone, everywhere our clients, partners, their stakeholders, communities, and the planet. As a company, we are deeply focused on accelerating our ESG agenda. We are also creating technology-enabled sustainable solutions with and for our clients and partners. We embed ESG imperatives into every aspect of our business and ensure that the progress we supercharge is responsible, inclusive and beneficial to all our stakeholders in the long term. We have committed to achieving net zero by 2040.

To learn more about how we can supercharge progress for you, visit www.hcltech.com

AEM Senior Technical Specialist with JavaScript, HTML/css

Job Summary
The Senior Technical Specialist in this role will be responsible for overseeing the development and maintenance of web applications and interfaces using HTML, Cascading Style Sheet(CSS), JavaScript, aem. They will play a key role in designing, implementing, and testing web based platforms to ensure optimal performance and user experience. (1.) Key Responsibilities
1. Develop and implement user-friendly web interfaces using html, css, and javascript
2. Collaborate with cross functional teams to design and deploy web applications
3. Create and maintain technical documentation related to web development projects
4. Troubleshoot and resolve technical issues to ensure smooth functioning of web platforms
5. Utilize aem (adobe experience manager) to manage and deliver digital experiences across multiple channels
6. Stay updated on the latest industry trends and technologies in web development

Skill Requirements
1. Proficiency in html, css, javascript, and aem (adobe experience manager)
2. Strong understanding of responsive web design principles
3. Experience with frontend frameworks such as bootstrap or angularjs
4. Knowledge of web development tools and technologies
5. Excellent problem-solving and analytical skills
6. Effective communication and teamwork abilities

Certifications: Relevant certifications in HTML5, CSS, JavaScript, or AEM are a plus

Skill Level 3 (Secondary Skill 1)

Technical Skills (APPS)-Web Development-JavaScript

Skill Level 3 (Secondary Skill 2)

Technical Skills (APPS)-Web Development-HTML

Skill Level 3 (Secondary Skill 3)

Technical Skills (APPS)-Web Development-Cascading Style Sheets (CSS)

Skill Level 3 (Secondary Skill 4)

Customer Experience Platform-Adobe-Adobe Analytics

","hiringOrganization":{"@type":"Organization","name":"HCLTech","sameAs":"https://www.hcltech.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"INDIA, Noida","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":45,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-08-05","description":"

About Business:

Adani Group: In recent years, we have evolved from a new player in power generation to India’s largest private thermal power producer, with a capacity of 15,250 MW and a 40 MW solar project in Gujarat. It has created a world-class logistics and utility infrastructure portfolio that has a pan-India presence. Adani Group is headquartered in Ahmedabad, in the state of Gujarat, India. Over the years, Adani Group has positioned itself to be the market leader in its logistics and energy businesses focusing on large-scale infrastructure development in India with O & M practices benchmarked to global standards. With four IG-rated businesses, it is the only Infrastructure Investment Grade issuer in India.

Adani Power Limited (APL): Adani Power Limited (APL), a part of the diversified Adani Group, is the largest private thermal power producer in India.We have a power generation capacity of 15,250 MW comprising thermal power plants in Gujarat, Maharashtra, Karnataka, Rajasthan, Chhattisgarh, Madhya Pradesh, and Jharkhand, and a 40 MW solar power project in Gujarat.

Job Purpose: This role is responsible for reviewing and finalizing engineering schemes related to switchyard protection systems. This includes supporting projects, conducting technical evaluations, performing root cause analysis, coordinating system upgrades, participating in audits, and providing training. The role ensures compliance with technical standards and regulatory requirements while supporting the project and O&M teams.

Team Lead - Switchyard Systems Protection, Protection Audits, Systems Studies

Engineering Review and Finalization:

Review engineering schemes related to the switchyard, ensuring they meet technical and operational standards.

Finalize engineering schemes after thorough review, making necessary adjustments and optimizations.

Collaborate with the Quality department to assist in quality inspections of the finalized schemes, ensuring they adhere to required standards.

Project Support:

Provide detailed technical specifications to the engineering team to ensure proper equipment sizing and compatibility with system requirements.

Support the tendering process by addressing technical queries during discussions and conducting comprehensive technical evaluations of potential vendors.

Review submitted schemes from Adani's side after contract awards, ensuring they align with project goals and standards.

Oversee the entire product preparation process, ensuring all technical requirements and specifications are met.

Conduct Factory Acceptance Tests (FAT) to verify that the product meets all operational and safety standards before deployment.

Witness the commissioning of products at the site, ensuring proper installation, integration, and functionality.

Provide technical support to the project team during the commissioning of protection systems, ensuring all procedures are followed correctly.

Assist in the system charging process, verifying that all protection systems are operational and meet regulatory standards.

Review commissioning documents required for regulatory approvals, ensuring accuracy and completeness, and submit them to the appropriate authorities.

OEM and Maintenance Support:

Conduct Failure Mode and Effects Analysis (FMEA) to evaluate potential failure points and their impacts on the system.

Provide technical recommendations and corrective actions from an electrical system perspective to address identified issues.

Support Annual Overhaul (AOH) and Capital Overhaul (COH) processes by providing technical expertise and ensuring all protection systems are maintained and upgraded as necessary.

Conduct annual internal protection audits to evaluate the effectiveness of current systems and identify areas for improvement.

Coordinate external protection audits every five years, working with third-party auditors to ensure compliance with industry standards.

Manage regular system upgrades, including identifying needs, budgeting, collaborating with OEMs, and overseeing the completion of upgrades.

Coordinate relay settings reviews and provide recommendations based on changes in grid conditions to ensure optimal system performance.

Regulatory and System Studies:

Participate in monthly meetings with government regulators, such as regional power committees.

Prepare and present detailed data on system health and any grid occurrences to the Team Lead Protection for submission to authorities.

Conduct comprehensive power systems studies, including load flow, short circuit, transient stability, and electromagnetic transient (EMT) studies for new plant power evacuation.

Training and Development:

Provide protection-related training to internal and external site engineers to enhance their knowledge and skills.

Develop detailed training materials and conduct workshops to ensure all team members are well-versed in protection systems and procedures.

Conduct technical audits to ensure compliance with standards and identify areas for improvement, providing detailed reports and action plans.

Root Cause Analysis (RCA):

Conduct Root Cause Analyses for equipment failures and ensure implementation across all sites.

Provide recommendations and ensure RCA findings are integrated into maintenance plans.

Investigate recurring failures across units and propose solutions under the guidance of the Head of Department (HOD).

Management of Change (MOC):

Propose and approve Management of Change (MOC) initiatives to enhance performance, reliability, and safety.

Evaluate and approve all MOC proposals related to switchyard protection systems.

Mergers and Acquisitions (M&A):

Conduct technical due diligence for switchyard protection systems-related aspects in Mergers and Acquisitions (M&A) activities.

Review equipment designs, site operations, and provide red flags and cost implications.

Assess ongoing disputes, equipment issues, and contracting terms.

Provide comprehensive due dilliegence report and cost estimates to the Business Development (BD) team.

Digitisation and Automation:

Execute comprehensive digitization strategies to optimize operational efficiency.

Implement automation solutions to support overall organizational goals/strategy.

Implement process and system improvements, adopting newer technologies and innovative ideas.

People and Team Engagement:

Participate in the recruitment process to attract and retain skilled personnel for the team.

Enhance employee engagement across the team to sustain a positive workplace culture.

Lead, inspire, and mentor the team to foster a high-performance culture and ensure cross-skilling through job rotation, technical, and behavioral trainings.

Ensure proper succession planning in the team.

Foster a conducive environment for high employee retention by ensuring team satisfaction and professional development.

Key Stakeholders - Internal

Operations & Maintenance (O&M) Team

Projects Team

Quality Team

ENDORSE Team

Techno Commercial Team

Business Development Team

MASS Team

Safety Team

Training Team

Key Stakeholders - External

Original Equipment Manufactures (OEMs)

Government Regulators

Consultants

Educational Qualification:

B.E./ B.Tech Electrical

Work Experience (Range of years):

Minimum 9 years of experience in similar systems, with extensive knowledge of switchyard protection systems, audits, and system studies.

Preferred Industry:

Background in Power and Utilities sector with knowledge of latest technologies and trends in switchyard protection systems

","hiringOrganization":{"@type":"Organization","name":"Adani Group","sameAs":"https://www.adani.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Mundra, Gujarat, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":46,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-08-11","description":"

Line of Service

Tax

Industry/Sector

Not Applicable

Specialism

Industry Tax Practice

Management Level

Senior Manager

Job Description & Summary

Education (if blank, degree and/or field of study not specified)

Degrees/Field of Study required:

Degrees/Field of Study preferred:

Certifications (if blank, certifications not specified)

Required Skills

Optional Skills

Desired Languages (If blank, desired languages not specified)

Travel Requirements

Not Specified

Available for Work Visa Sponsorship?

Government Clearance Required?

Job Posting End Date

","hiringOrganization":{"@type":"Organization","name":"PwC","sameAs":"https://www.pwc.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Melbourne, Australia","addressCountry":"Australia","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":47,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-08-02","description":"

At Bristol Myers Squibb, we are creating innovative medicines for patients who are fighting serious diseases. We are also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

The Senior Manager, FP&A will be a highly collaborative Finance business partner. This exceptional leader will act as a “player-coach,” overseeing and supporting execution of FP&A activities for the team in BMS’s Hyderabad Hub and demonstrate the following attributes:

Exceptional expertise in financial planning, forecasting, budgeting, and financial modelling
Outstanding ability to forge strong partnerships with fellow Hub team members and broader Finance colleagues to provide high quality services in a timely fashion
Open communication and cooperation to ensure the FP&A Hub in Hyderabad remains an integral part of the local FP&A teams, aligned to broader vision and strategy, and contributes to the overall success of the Finance function and BMS

Successful candidates will possess excellent leadership skills, inspiring and motivating team members to deliver exceptional results.

A minimum of 7-9 years of experience is required.

The position will be based in BMS’s Hyderabad Location (expected 50% in-person) with minimal travel expected.

Key Responsibilities and Major Duties:

FP&A activities

Leads team and supports execution of cost center management and alliance management activities for business unit FP&A COE and senior management consumption
Builds and reviews budget and projections for supported business units
Provides effective analyses to clearly highlight key trends / variances and rationale
Prepares presentations for budget & projection reviews; updates forecast templates as needed
Prepares analysis of monthly actual variances vs. budget / projection in alignment with standard framework and templates
Manages and executes special projects, ad-hoc analysis to ensure highly effective outcomes

Process standardization and improvement

Support the development and execution of a global strategy for policies, processes, and technologies
Define and establishing consistent end to end process and collaborate with data owners / stewards to align on process and data issues
Propose forecasting improvement projects with a focus on delivering key business outcomes
Develop the business case for process improvement decisions and tracks actuals against the plan to validate execution and improve future plans
Participate in process governance
Identify, design and incorporate industry leading practices into standard operations within the Hyderabad Hub necessary to identify and raise/resolve issues involving tradeoffs, especially around cost, quality, and customer service
Maintain to a culture of continuous improvement at all levels of the organization and foster a business-oriented culture; continuously monitor the needs of the business
Solicit feedback from internal customers to determine the best response to continually improve process performance and year-over-year cost reductions
Ensure and continually validate operating procedures that are established and documented to support execution and are maintained to align with process changes

Relationship management and teaming

Interacts with business unit FP&A COE and serves as an inspirational and engaging leader who motivates and engages through clear articulation of FP&A priorities for the business unit
Shares leading practices and learning with other Hub sub-tower teams and collaborates to drive process standardization and innovation
Assists in recruiting, hiring, and retaining of strong local team members as well as training and upskilling
Holds self and others to timelines, quality, and accuracy

On-site Protocol

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

","hiringOrganization":{"@type":"Organization","name":"Bristol Myers Squibb","sameAs":"https://www.bms.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hyderabad, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":48,"item":{"@type":"JobPosting","title":"Senior Manager","datePosted":"2025-08-04","description":"

Job Description:

About us*

At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day.

One of the keys to driving Responsible Growth is being a great place to work for our teammates around the world. We’re devoted to being a diverse and inclusive workplace for everyone. We hire individuals with a broad range of backgrounds and experiences and invest heavily in our teammates and their families by offering competitive benefits to support their physical, emotional, and financial well-being.

Bank of America believes both in the importance of working together and offering flexibility to our employees. We use a multi-faceted approach for flexibility, depending on the various roles in our organization.

Working at Bank of America will give you a great career with opportunities to learn, grow and make an impact, along with the power to make a difference. Join us!

Global Business Services

Global Business Services delivers Technology and Operations capabilities to Lines of Business and Staff Support Functions of Bank of America through a centrally managed, globally integrated delivery model and globally resilient operations.

Global Business Services is recognized for flawless execution, sound risk management, operational resiliency, operational excellence and innovation.

In India, we are present in five locations and operate as BA Continuum India Private Limited (BACI), a non-banking subsidiary of Bank of America Corporation and the operating company for India operations of Global Business Services.

Process Overview*

Global Markets Business Finance & Control (BF&C) is a division of Global Banking & Markets (GBAM) Finance responsible for the production and independent validation of Global Markets' profit and loss and balance sheet. In this regard, BF&C will ensure, inter alia, that accounting policies are correctly and consistently applied, and that trading portfolios are appropriately valued.

The team prepares and reports P&L and balance sheet to the business and ensures the accuracy and integrity of the general ledger. We are responsible for daily service delivery and ensuring effective controls, transparent management information and becoming a center of excellence delivering process simplification and efficiencies. We work closely with front office, middle office, traders and valuation control teams to drive the control agenda across the business.

Job Description*

Global Markets Business Finance & Control (BF&C) seeks to provide a support service with particular focus on the relationship between trading risk positions and P&L components. We are looking to recruit an individual to work in the P&L production area covering the Global Rates Trading desks. The candidate’s main responsibility will be to produce and deliver the daily P&L to front office, providing a high standard of analysis and explanation around any issues faced and daily revenue drivers. The candidate will therefore have considerable interaction with the respective Front Office, Middle Office, and Finance and Trade Capture teams so good communication and time management skills are an essential requirement for this job.

Primary products covered will include Fixed Income, Money markets, interest rate derivatives, FX derivatives.

Responsibilities*

Perform Production and Reporting of daily P&L and balance sheet to Front Office & Senior Management.
Perform Reconciliation of actual P&L with trader estimates and review flash/actual variance analysis.
Work closely with the trading desks on position, P&L or other issues on an ad-hoc basis.
Review Front-to-Back analysis & reconciliations of front office P&L and Balance Sheet to firm sub-ledgers,
Assist with execution of month-end controls ensuring management vs financial P&L variances are within thresholds
Analyze traders’ risk positions and understand and apply the Greeks (Delta, Vega Gamma) vs daily market moves.
Control books, cost center and Business Units for line of business
Liaise with various business partners such as Technology, Market Risk, Credit Risk, Operations and Finance to resolve issues / queries.
Develop, standardize & continuous improvement of existing processes & workflow.
Monitor Testing/UAT for existing or new systems
Remediation of issues in an autonomous yet timely manner considering the principles of control and the need to mitigate operational risk
Optimize Operational Excellence – act as innovator and change catalyst to drive process redesign and realize efficiency across the platform
Manage and drive risk disciplines and internal controls to deliver the best outcomes for our clients and shareholders
Be pro-active and engage control partners/ technology to identify and mitigate operational risks
Build a culture and process to identify, mitigate, and control operational risk.

Requirements*

Education*

Qualified Chartered Accountant/CPA /CFA / MBA from Tier I/II institute with relevant experience in Product Control or Global Markets environment and organization of similar scale with US GAAP, IFRS, IAS reporting framework with an interest and aptitude for derivative products

Certifications If Any

• CFA / FRM certified candidates would be preferred

• Advanced education and/or enhanced technical qualifications are a plus

Experience Range*

5 to 7 years with at least 4+ years’ experience in Global Markets

Foundational skills*

Should have good understanding of financial markets, Derivatives & structured notes-their hedging, funding, credit risk etc.
Line experience coupled with a demonstrated ability to lead technology-based change.
Proven experience of providing thought leadership to overcome challenges and lead without direct authority, excellent skills with an ability to manage the group of fast paced team supporting multiple business verticals.
Strong verbal and written communication skills, and the personal ability to collaborate, operate, and communicate effectively with a culturally diverse group of peers and colleagues.
Has the gravity to interact at all levels of management to support resolution of complex business issues.
Demonstrated ability to work in a globally matrixes and significantly multi-geography, multi-cultural offshore service delivery environment.
A convincing executive presence which conveys composure and confidence in all situations, the credibility and stature to carry stakeholders through influence rather than via the hierarchy.
Individual should have the resilience to handle internal pressures and conflicts in dealing with multiple stakeholders.

Desired skills

Alteryx / Python / Tableau knowledge would be an added advantage.
Must be proactive and be a highly motivated self-starter
Effective communication skills with English proficiency
Demonstrated ability to work in a high pressure environment
Takes initiative and challenges existing processes and procedures in a proactive manner
Strong team player
Ability to analyze issues independently and derive solutions
Analytical skills
Inherent sense of principles of control through experience and sound judgment
Reliability

Work Timings*

12:30 PM IST to 9:30 PM IST

Job Location*

Mumbai/ Gurugram

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Job Description:

About Us

Working at Bank of America will give you a great career with opportunities to learn, grow and make an impact, along with the power to make a difference. Join us!

Global Business Services

Global Business Services is recognized for flawless execution, sound risk management, operational resiliency, operational excellence and innovation.

Process Overview

Strategic Solutions & Enablement is a strategic execution team that delivers process redesign, business intelligence, and technical solutions, enabling the delivery of solutions that simplify and improve our processes and the way we work. Business Intelligence Data Strategy is the sub team within GDRO SSE that provides process automation and BI solutions at GMO level.

Job Description

Work for SSE projects at GMO level for eTask Product / UAT
Individual Contributor having knowledge and experience to provide solutions for eTask Product workflow management tool
Having knowledge, expertise and ability to think beyond and be proactive to identify issues and add value on the overall strategy for eTask workflow management tool.
Perform Product Owner responsibilities so that the team successfully delivers the planned functionality into production, without bugs and on time
Ensure test scripts accuracy, completeness, & MRA adherence
Monitor Dev and UAT progress during Sprints, Perform PO testing and Validate QA test evidence
Story creation, Story grooming and prioritization, Release planning and Post-production validation testing.
Prepare data and UAT test scripts for business/ UAT testers and post release validation testing. Coordinate with business testers during UAT window for post release

Responsibilities

Individual contributor with knowledge and experience as Product Owner and UAT role
Incumbent must have interest in working as project management / analysis work and E2E Product and UAT
Prioritize enhancement request and pre and post benefit with ROI / funding estimates
Production support: E2E management of all production issues
Product / UAT support: E2E management of all Product / UAT work including.

Create User stories, UAT Test scripts, Review test scripts with Dev (tech team) for completeness.
Partner with Dev and QA team in tech along with UAT testers
Test new features in Dev and QA environment (as needed).
Host business validation / check in calls

Requirements

Education - BCE / Computer Science / MBA

Experience Range – 9-11 yrs

Foundational skills:

PO (Product Owner) tester role
Excels in working among diverse viewpoints to determine the best path forward
Excellent communication and influence skills across multiple levels / diverse audiences, proven ability to influence without formal authority
Strives to bring new thoughts and ideas to teams to drive innovation and unique solutions

Desired skills:

Experience working in Capital Markets / IB Domain / Global Markets Operations
Must be collaborative / curious / driven / continuous learner
Commitment to challenging the status quo and promoting positive change

Work Timings: 12.30PM - 9.30pm

Job Location: GIFT / Hyderabad

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Work Location:

Toronto, Ontario, Canada

Hours:

37.5

Line of Business:

TD Securities

Pay Details:

$108,800 - $163,200 CAD

TD is committed to providing fair and equitable compensation opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The base pay actually offered may vary based upon the candidate's skills and experience, job-related knowledge, geographic location, and other specific business and organizational needs.

As a candidate, you are encouraged to ask compensation related questions and have an open dialogue with your recruiter who can provide you more specific details for this role.

Job Description:

Payments Investigations:

Lead and manage a team of 65+ Payment Professional in Canada, Singapore and India responsible for global investigations for incoming and outgoing SWIFT MT and ISO 20022 (MX) messages (e.g., MT103, MT202 COV, pacs.008).
Oversee resolution of exceptions, returns, NACKs, and claims (e.g., fraud, duplicate payments, recall requests) in compliance with SWIFT, AML, and bank policy.
Drive root cause analysis (RCA) and implement remediation for recurring payment issues or client-impacting errors.

Help Desk Operations:

Manage 24/6 support model for SWIFT-related inquiries from clients, internal desks, and FI correspondents.
Ensure service-level agreements (SLAs) are met and high client satisfaction maintained.
Lead escalation protocols, issue triage, and provide senior-level support for complex or high-value issues.

Leadership & Strategy:

Define KPIs and operational performance metrics for help desk and investigations teams.
Develop and execute team strategies aligned with global payment modernization initiatives (ISO 20022, CBPR+, etc.).
Hire, mentor, and develop staff, fostering a culture of continuous improvement and client-first mindset.
Work with larger GPDO team, including Deposit Operations, Wire Payment Operations, Sanction Transaction Group, Senior Industry Leads, Payment Controls Team (Lynx FMI , Payments Canada, Bank of Canada) Payments Risk and Compliance to create and develop strategies around Employee experience, Client Experience and Shareholder value.

Risk, Controls & Governance:

Ensure controls are in place and effective to mitigate operational, regulatory, and reputational risk.
Serve as key liaison for audits, compliance reviews, and regulatory inquiries (e.g., SWIFT CSP, MAS, OSFI, FINTRAC, OCC, FED).
Contribute to policies and procedures for payment exception handling and customer complaint resolution.

Collaboration & Transformation:

Partner with product, technology, sanctions compliance, AML, and operations teams to enhance automation and exception resolution flows.
Provide SME input into payment system upgrades, platform migrations, or process reengineering projects (e.g., AI case triage, RPA).
Represent the firm in external SWIFT forums or industry working groups as needed.

Qualifications:

Bachelor’s degree required; advanced degree or professional designation (e.g., CAMS, ACAMS, CTP, PMP) is a strong asset.
5-10+ years of experience in global payments operations, with direct leadership of SWIFT investigations or client services.
Deep knowledge of SWIFT messaging standards (MT and ISO 20022), correspondent banking, and cross-border wire processing.
Familiarity with AML/sanctions screening and payment compliance procedures.
Experience managing operational teams, setting KPIs, and leading through change in a high-pressure environment.
Strong communication, conflict resolution, and stakeholder management skills.
Experience with case management platforms (e.g., Intellitracs, PMG, SWIFT GPI etc) is an asset.
Strong analytical mindset, with ability to interpret data and identify trends or process bottlenecks.

Preferred Experience:

Experience in a G-SIB, global transaction bank, or high-volume FI payments hub.
Exposure to Fedwire, CHIPS, LYNX, TARGET2, or other real-time gross settlement (RTGS) systems.
Familiarity with SWIFT gpi, Universal Confirmations, and case resolution standards (CAMT messages).

Who We Are:

TD Securities offers a wide range of capital markets products and services to corporate, government, and institutional clients who choose us for our innovation, execution, and experience. With more than 6,500 professionals operating out of 40 cities across the globe, we help clients meet their needs today and prepare for tomorrow. Our services include underwriting and distributing new issues, providing trusted advice and industry-leading insight, extending access to global markets, and delivering integrated transaction banking solutions. In 2023, we acquired Cowen Inc., offering our clients access to a premier U.S. equities business and highly-diverse equity research franchise, while growing our strong, diversified investment bank. We are growth-oriented, people-focused, and community-minded. As a team, we work to deliver value for our clients every day.

Our Total Rewards Package
Our Total Rewards package reflects the investments we make in our colleagues to help them and their families achieve their financial, physical, and mental well-being goals. Total Rewards at TD includes a base salary, variable compensation, and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off, banking benefits and discounts, career development, and reward and recognition programs. Learn more

Additional Information:
We’re delighted that you’re considering building a career with TD. Through regular development conversations, training programs, and a competitive benefits plan, we’re committed to providing the support our colleagues need to thrive both at work and at home.

Please be advised that this job opportunity is subject to provincial regulation for employment purposes. It is imperative to acknowledge that each province or territory within the jurisdiction of Canada may have its own set of regulations, requirements.

Colleague Development
If you’re interested in a specific career path or are looking to build certain skills, we want to help you succeed. You’ll have regular career, development, and performance conversations with your manager, as well as access to an online learning platform and a variety of mentoring programs to help you unlock future opportunities. Whether you have a passion for helping customers and want to expand your experience, or you want to coach and inspire your colleagues, there are many different career paths within our organization at TD – and we’re committed to helping you identify opportunities that support your goals.

Training & Onboarding
We will provide training and onboarding sessions to ensure that you’ve got everything you need to succeed in your new role.

Interview Process
We’ll reach out to candidates of interest to schedule an interview. We do our best to communicate outcomes to all applicants by email or phone call.

Accommodation
Your accessibility is important to us. Please let us know if you’d like accommodations (including accessible meeting rooms, captioning for virtual interviews, etc.) to help us remove barriers so that you can participate throughout the interview process.

We look forward to hearing from you!

Language Requirement (Quebec only):

Sans Objet","hiringOrganization":{"@type":"Organization","name":"TD","sameAs":"https://www.td.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"TD Centre - North - 77 King Street West, Toronto, Ontario, Canada","addressCountry":"Canada","addressRegion":"North America"}}}}]}

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