VP, Biometrics
Core
Lead biometrics across the full drug development lifecycle (IND to post-approval) for antibody-based medicines, building a world-class function from the ground up.
Role type
VP, Biometrics (Strategic & Hands-on IC)
Builds
Biostatistics, statistical programming & analysis, and clinical data management functions for Phase 1-4 trials.
Domain
Biotechnology / Clinical Development / Biostatistics
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biostatistics, Statistical programming, Clinical data management, Regulatory submissions (NDA/BLA), ICH guidelines, GCP, CDISC standards, Team leadership, Vendor/CRO management
Preferred skills
Experience in both large and small organizations, End of phase meeting representation, Board advisory experience
Technologies
SAS, R, CDISC standards, Clinical trial management systems
Responsibilities
Build and maintain high-performing biometrics teams; Shape clinical data strategy and study designs; Partner with clinical development and regulatory affairs; Oversee external consultants and CROs; Ensure adherence to global regulatory standards; Advise stakeholders on quantitative methodologies; Partner on regulatory document creation.
Seniority
VP, Strategic & Hands-on IC
