Senior Biostatistician

About the role

The Senior Biostatistician will work under the general direction of the Associate Director, Biostatistics in providing statistical support to Health Economics and Outcomes Research (HEOR), Real World Evidence (RWE), and Market Access activities in support of drug development and commercialization. This role contributes to statistical aspects of assigned studies or projects to ensure that scientific, regulatory, and quality requirements are met and that plans are aligned with development and commercialization goals. The incumbent will provide statistical knowledge in study design, statistical analysis, reporting, and interpretation of data, and will collaborate with cross-functional teams composed of internal and/or external experts.

Responsibilities

• Provide statistical support to clinical studies or projects under the guidance of senior Biostatistics leadership.
• Collaborate with cross-functional teams in support of HEOR, RWE, and Market Access activities.
• Contribute to the planning and execution of analyses of clinical trial data, claims databases, electronic medical records, disease registries, or other epidemiological data sources in coordination with the HEOR/RWE, Market Access, and Biometrics teams.
• Work directly with study/project teams to identify statistical issues and propose appropriate solutions.
• Provide statistical input to study reports, value/reimbursement dossiers, publications, and other internal or external data requests.
• Perform statistical modeling and analyses as needed.
• Prepare and review analysis plans, case report forms, database specifications, validation plans, TFL shells, analysis datasets specifications, and supporting documentation for observational studies or clinical trials.
• Review analytical work conducted by colleagues, external collaborators, or third-party service providers and escalate issues as appropriate.
• Collaborate with internal and/or external Biometrics teams to support timely and high-quality study/project deliverables.
• Contribute to the development and refinement of Biometrics-related SOPs, work practice documents, and technical standards.
• Apply established statistical methodologies to transform data into actionable insights to support decision making.
• Additional duties assigned as needed.

Requirements

• Bachelor’s degree in Statistics/Biostatistics, Computer Science, Mathematics, Epidemiology, Health Economics or related technical discipline required. Master’s Degree in Statistics/Biostatistics or related quantitative field preferred. Equivalent combination of education and applicable job experience may be considered.
• 4+ years of relevant experience in the biopharmaceutical industry or healthcare system required.

Skills

• Strong understanding of fundamental statistical principles, best practices, and industry standards applicable to HEOR, RWE, and Market Access.
• Hands-on experience in extracting, organizing, and analyzing data from SDTM and ADaM datasets, and/or claims databases, electronic medical records, registries, or other epidemiological data sources.
• Experience with study designs, power/sample size computations, longitudinal data analysis, survival analysis, cost-effectiveness analysis, statistical modeling, and simulation.
• Proficiency in R or SAS programming.