Senior Principal Statistician, Biometrics
Core
Design, execute, analyze, and report on clinical development programs and real-world evidence (RWE) studies to inform regulatory and business decisions.
Role type
Senior Principal Statistician (Biometrics)
Builds
Clinical study reports, regulatory submissions, and integrated evidence generation strategies combining clinical trial and real-world data.
Domain
Biopharmaceuticals / Clinical Development / Real-World Evidence
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical programming (R, SAS), observational data analysis (synthetic control arms, target trial emulation, causal inference), clinical trial design, regulatory submission support, gap analysis, due diligence evaluation
Preferred skills
Master's or PhD in Statistics/Biostatistics, experience with registry/claims data, life cycle management strategy
Technologies
R, SAS
Responsibilities
Support design, conduct, analysis, and reporting of RWE studies; Author statistical analysis plans and contribute to study design; Critically review clinical trial data to assess asset value and label expansion opportunities; Conduct gap analyses to identify data limitations affecting regulatory approval; Provide independent analyses of key endpoints to validate asset potential
Seniority
Senior, hands-on IC
