Principal Scientist, Biostatistics, Clinical Safety Statistics

Role: Lead statistical safety evaluation within the Clinical Safety Statistics (CSS) group for Oncology Therapeutic Area programs, providing expertise in safety monitoring, analysis, and risk assessments throughout product development and post-marketing. Responsibilities: develop strategic safety plans, partner with cross-functional teams (Risk Management, Epidemiology, Data Programming), design innovative statistical methods, ensure compliance with regulatory standards, and communicate safety findings to stakeholders. Requirements: PhD or MSc in statistics, biostatistics, or related, with at least 6 years (PhD) or 9 years (Master's) of relevant experience; strong knowledge of survival analysis, meta-analysis, Bayesian methods, SAS or R proficiency, and regulatory safety data analysis. Preferred: understanding of drug/vaccine development stages from preclinical to post-marketing, interest in novel statistical/machine learning methods, and publication record. High-Value: Oncology therapeutic area, safety analysis, regulatory compliance, clinical trial and real-world data expertise, experience with safety monitoring tools. Work Setup: hybrid in the US; approximately 10% travel.