Senior Manager, Biostatistics
Core
Lead statistician for complex clinical studies in cell therapy oncology programs, overseeing study design, analysis, and regulatory documentation.
Role type
Senior Manager, Biostatistics (Lead Statistician)
Builds
Clinical study reports, regulatory submissions (NDA/BLA), and statistical analysis plans for TIL and gene-edited cell therapy programs.
Domain
Oncology / Cell Therapy / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Survival analysis, patient-reported outcome analysis, health economics, SAS proficiency, regulatory guidance knowledge, cross-functional leadership, study design, statistical programming oversight
Preferred skills
FDA/EMA/ICH guidance expertise, NDA/BLA/MAA submission experience, R programming
Technologies
SAS, R
Responsibilities
Lead statistical activities for assigned clinical studies; author and review statistical sections of protocols, analysis plans, and clinical study reports; collaborate with CROs and programmers to ensure timely delivery; contribute to process improvements and statistical best practices.
Seniority
Senior Manager, hands-on IC with strategic oversight