Principal Biostatistician - Safety (FSP)
Core
Principal Biostatistician supporting clinical research programs for a biotechnology company developing therapies for autoimmune diseases and oncology, focusing on safety, regulatory reporting, and statistical analysis.
Role type
Principal Scientist in Biostatistics (Functional Service Provider)
Builds
Scientific evidence for clinical trials and regulatory submissions
Domain
Biotechnology / Clinical Research / Biostatistics
Required skills
SAS programming, statistical methodology, ICH-GCP guidelines, clinical trial regulations, statistical analysis plan development, benefit-risk analysis, safety reporting (DSUR, PSUR), post-marketing analysis, CDISC standards, R, WinBUGS
Preferred skills
Experience in CRO environment, vendor management, auto-immune or oncology therapeutic areas
Technologies
SAS, R, WinBUGS, EAST
Responsibilities
Implement statistical tasks throughout the full clinical trial process (study design, protocol writing, final analysis, reporting), develop and review statistical analysis plans, conduct benefit-risk analysis and safety reporting, interact with regulatory authorities (FDA, EMA), manage multiple clinical trials simultaneously
Seniority
Principal, hands-on IC with strategic oversight