Senior Scientist, Biostatistics, Clinical Safety Statistics

Responsibilities:

• Provide statistical support for program-level evaluation of clinical safety data.
• Collaborate with cross-functional safety teams to plan and execute ongoing safety evaluations across pre- and post-marketing development stages.
• Design, develop, and evaluate processes/tools for product safety evaluation, including ongoing aggregate safety evaluation at the program level.

• Support strategic planning and scientific reasoning for safety evaluations.
• Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety.
• Design and apply safety evaluation methods, processes, standards, and tools (including enhanced graphical analyses).
• Collaborate with statisticians and statistical programming staff to deliver high-quality outputs meeting analysis requirements and regulatory expectations.
• Prepare oral/written reports communicating safety evaluation results.
• Assess need for novel statistical methodology and suitability of software.
• Conduct research on innovative statistical methods for clinical safety evaluation.

• PhD (or equivalent) in statistics/biostatistics or related field, or Master’s plus 3+ years relevant experience.

• Study design and statistical analysis knowledge (survival analysis, meta-analysis, Bayesian).
• SAS and R (R-Shiny a plus) for statistical/data processing.
• Strong oral/written communication and cross-functional collaboration.
• Initiative, attention to detail, high-quality execution, and ability to manage multiple priorities.

• CDISC (SDTM, ADaM), observational epidemiology methods (confounding control), AI tools for writing/programming, regulatory knowledge for safety signal detection/evaluation/reporting, drug discovery/development and disease biology; interest in publication/research.