[R&D] Statistician/統計担当者

Job Summary

• Design, analyze, and interpret clinical trials/post marketing surveillance (PMS) in compliance with relevant regulatory requirements, company standards and best practices
• Provide scientifically rigorous statistical expertise and contributions by working effectively within the clinical triad (clinician, clinical pharmacologist, and statistician)

Job Responsibilities

• Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
• Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
• Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
• Develop effective collaborations with others within clinical teams, partner lines, and external regulatory, industry, professional and academic organizations.
• Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and company standards.
• Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
• Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, Data managers (i.e., Clinical Data Scientist), Clinical Programming colleagues (i.e., Statistical Data Sciences Lead) – for assigned studies/PMS and regulatory submissions.
• Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
• Comply with all statistics and quality processes and company's data standards that are applicable to statistical outputs, and support processes that require statistical input.
• Communicate and collaborate with global Therapeutic Area (TA) statisticians on assigned projects.
• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
• Participate in research on statistical methodology and its applications to clinical trials/PMS.

Qualifications / Skills

Behavioral Skills:

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

• Consulting Skills

• Capability to provide statistical leadership to cross-functional teams

Technical Skills:

• Strong statistical/epidemiological skills with application to clinical trials/PMS
• A broad understanding of drug development
• Knowledge of clinical medicine and regulatory requirements

Education/Certification:

• Advanced degree in statistics, biostatistics, or related field

Languages:

• Written and oral communication skills in English to effectively communicate with TA statisticians

 
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical