Lead Biostatistician - PV focus
Core
Statistical lead for high-profile pharmacovigilance (PV) and safety-focused observational studies using complex longitudinal registry data to generate real-world evidence.
Role type
Senior IC lead biostatistician (pharmacovigilance/safety)
Builds
Real-world evidence for post-authorization safety studies (PASS) and regulatory commitments
Domain
Life sciences / Pharmacovigilance / Real-world evidence
Deliverable
production ML models | dashboards & analysis
Required skills
Advanced statistical analysis, study design, sample size/power calculations, R programming, longitudinal data analysis, observational study design, causal inference, regulatory safety study support, mentoring junior staff
Preferred skills
SAS programming, pharmacovigilance project lead experience, causal inference theory, peer-reviewed publication experience
Technologies
R, SAS
Responsibilities
Lead statistical design, analysis, interpretation, and reporting of PV and safety-focused observational studies; Develop protocols, Statistical Analysis Plans (SAPs), and analytic strategies; Perform advanced statistical analyses and sample size/power calculations; Provide strategic statistical leadership for safety analyses and real-world evidence generation; Oversee and mentor Biostatistician I/II analysts; Develop standardized methodologies and analytical templates
Seniority
Senior, hands-on IC with leadership responsibilities