Senior Director, Biometrics
Core
Senior biostatistics leader providing strategic and operational oversight for biometrics and clinical data management across gene therapy clinical programs.
Role type
Senior Director, Biometrics (Strategic IC with line management)
Builds
Clinical trial statistical analyses, regulatory submission packages, and integrated biometrics/data management functions
Domain
Biotechnology / Gene Therapy / Clinical Development
Required skills
Clinical trial design, statistical methodology, regulatory interactions (FDA/EMA/ICH), data management strategy, vendor management, team leadership, study design, sample size calculation, interim analysis, clinical study reports
Preferred skills
Clinical Data Management leadership, rare disease experience, gene/cell therapy experience
Technologies
CDISC, SDTM, ADaM, SAPs, CRF design
Responsibilities
Define biometrics strategies for study design and endpoint selection; lead biostatisticians in protocol development and regulatory submissions; oversee clinical data management function including database build and validation; manage biometrics vendors and CROs; establish biometrics SOPs and mentor team members
Seniority
Senior Director, strategic leadership with hands-on oversight