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Principal Scientist, Biostatistics, Clinical Safety Statistics

Merck
September 30, 2026
Full-time
Remote friendly (North Wales, PA)
Worldwide
Clinical Research and Development
Role: Lead statistical safety evaluation within the CSS group for Oncology Therapeutic Area programs, providing scientific expertise and strategic oversight for safety data analyses throughout the product lifecycle. Responsibilities: partner with cross-functional teams to design and interpret safety analyses; develop innovative statistical methods and tools for safety monitoring; communicate findings to stakeholders, including regulators. Qualifications: PhD or equivalent in statistics, biostatistics, with 6+ years (or MS with 9+ years) of relevant experience; strong expertise in survival analysis, meta-analysis, Bayesian methods, and statistical software (SAS/R); knowledge of regulatory safety requirements, clinical trial design, and real-world data analysis. Preferred: knowledge of drug development stages from preclinical to post-marketing, experience with AI tools, and understanding of disease biology. High-Value: focus on oncology safety data, comprehensive safety analysis throughout product development, and collaboration with Risk Management Safety Teams. Work setup: hybrid in the US with approximately 10% travel.