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 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 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. #J-18808-Ljbffr Merck