Manager of Statistical Programming
Core
Lead statistical programming for oncology clinical trials, generating regulatory submission deliverables (ADS, TLF) and maintaining R-based analysis infrastructure.
Role type
Manager of Statistical Programming (Clinical Trials)
Builds
Regulatory submission packages (510(k), CTA/CDx, PMA) and R Shiny dashboards for data review.
Domain
Oncology diagnostics / Clinical Trials / NGS
Required skills
R programming, package development, ADS/TLF generation, clinical trial analysis, regulatory compliance (ICH/GCP/FDA 21 CFR Part 11), team leadership
Preferred skills
NGS, genetics, oncology diagnostics, statistical computing environment maintenance
Technologies
R, R Shiny, ADS, TLF
Responsibilities
Lead statistical programming deliverables for regulatory submissions; manage team of programmers; maintain R package infrastructure; develop R Shiny dashboards; collaborate cross-functionally with Biostats and Data Management.
Seniority
Manager, hands-on IC with team leadership