Associate Director / Director, Clinical Data Science

Associate Director / Director, Clinical Data Science

The Clinical Data Scientist provides clinical and strategic support to the execution of the clinical strategy of assigned clinical programs under the supervision of the Head of Biometrics.  

Responsibilities:

• In collaboration with appropriate clinical trial team members, performs ongoing, high quality, clinical data review across programs, including at the patient level, facilitates resolution of data issues, supports database locks and provides input to final analyses and interpretation of data. May include extracting and analyzing clinical data using data visualization tools, SAS data listings and or other outputs, regularly, to identify trends and/or issues to be communicated and addressed with CRO.
• Assist with development of standards, processes and tools, including those for clinical data review and patient sample tracking, to ensure timely data-driven program decisions.
• Build effective relationship with CRO(s) to ensure CRO activities related to data management are timely, coordinated and complete; may serve as the main point of contact with data management team at CRO(s). 
• Contributes to creation of clinical sections of the Data Review / Quality Plan and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments and other aspects of the protocol are implemented consistently across the program.
• With appropriate guidance from the Clinical Development Lead for the program and/or Head of Biometrics, and dependent on the stage of trial prep / execution, may provide clinical and scientific input, and contribute to development of trial-related documents (e.g. clinical trial protocols, data analysis plans, reports, publications).
• Participates in protocol review to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs) for study conduct, metric development, and trend monitoring.
• Proactively anticipates and monitors risks and issues at the program level, implementing mitigation strategies and taking corrective measures.
• May provide input to clinical sections of Investigator Brochures, responses to Health Authorities / Institutional Review Boards / Ethics Committees; may write sections of clinical trial documents for study CSR activities.
• Engages with relevant external investigators.
• Maintains compliance with Good Clinical Practice guidelines and Treeline Standard Operating Procedures.

Qualifications:

• Advanced degree in life sciences / healthcare (or clinically relevant degree) PharmD, PhD or MSc. in a related discipline preferred
• At least 8 years of involvement in clinical research or drug development in a clinical operations or clinical scientific role, in industry setting. Oncology / hematology experience preferred
• Fundamental knowledge of the clinical trial process including data management processes
• Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
• Experience with selection and oversight of CROs
• Excellent communication skills, written and oral
• Strong interpersonal skills
• Ability to resolve issues with minimal supervision and understand when to escalate
• Ability to work independently and in a cross-functional team setting
• Working knowledge of Good Clinical Practice and drug development processes (e.g. clinical data collection and cleaning, ability to detect data trends etc.)
• Impeccable personal ethical integrity and a commitment to improving the outcomes for patients

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $160,553 to $217,379. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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