Manager of Statistical Programming
Core
Lead statistical programming for oncology diagnostic clinical trials, ensuring regulatory compliance and data integrity for submissions.
Role type
Manager of Statistical Programming
Builds
Analysis datasets (ADS), Tables/Listings/Figures (TLF), and R Shiny dashboards for regulatory submissions (510(k), CTA/CDx, PMA).
Domain
Oncology diagnostics / Clinical trials / NGS / Genetics
Required skills
R programming, package development, ADS/TLF generation, clinical trial analysis, regulatory compliance (ICH/GCP/FDA 21 CFR Part 11), team management
Preferred skills
NGS, genetics, oncology diagnostics, statistical computing environment maintenance
Responsibilities
Lead statistical programming deliverables, manage team development, act as primary programming lead for regulatory submissions, maintain programming infrastructure, develop R Shiny dashboards, promote best practices, work cross-functionally
Seniority
Manager, hands-on IC with team leadership