Associate Principal Biostatistician Clinical Safety Statistics (CSS)
Core
Lead statistical analysis and evaluation of clinical safety data for medical drugs and vaccines from IND through post-marketing phases.
Role type
Associate Principal Biostatistician (Clinical Safety)
Builds
Regulatory documents (DSUR, IB), aggregate safety evaluations, and statistical reports for safety signal identification.
Domain
Biopharmaceuticals / Clinical Safety Statistics
Deliverable
production ML models | dashboards & analysis
Required skills
Survival analysis, meta-analysis, Bayesian analysis, clinical trial design, SDTM/ADaM datasets, SAS, R, R-Shiny
Preferred skills
Regulatory safety signal evaluation, drug development lifecycle, statistical research, AI for writing/programming
Responsibilities
Design and evaluate processes for safety data evaluation, collaborate with cross-functional Risk Management Safety Teams, prepare oral and written reports for regulatory agencies, participate in research for innovative statistical methods.
Seniority
Senior, hands-on IC
