Role OverviewThe Principal Scientist, Biostatistics, Clinical Safety Statistics will lead safety monitoring and evaluation within the Clinical Safety Statistics group for key Oncology Therapeutic Area programs. The role requires statistical leadership and support to Risk Management Safety Teams in planning and executing compound-level safety evaluations throughout the product life cycle.
What You Will Do
Provide statistical leadership for compound safety evaluation strategies and analyses in the Oncology Therapeutic Area, support CSS projects in other therapeutic areas as needed, and communicate safety analysis results and recommendations to cross-functional teams, management, regulators, and investigators.
Why It Might Be a Fit
The successful candidate will have strong knowledge of statistical methods, regulatory requirements, and clinical trial design and analysis, with experience in developing or applying novel statistical methods for safety data monitoring, evaluation, and benefit-risk assessment.
Requirements
- PhD or equivalent degree in statistics, biostatistics, or a related discipline
- Strong knowledge of statistical methods, including survival analysis, meta-analysis, Bayesian methods, and approaches to control confounding
- Proficiency in statistical software, such as SAS or R
- Strong knowledge of regulatory requirements for analyzing and reporting safety data
- Knowledge of and experience in clinical trial design and analysis
- Strong communication, project management, and leadership skills
Benefits
- Medical, dental, vision healthcare and other insurance benefits
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
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