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)
Builds
Biostatistics, statistical programming & analysis, and clinical data management functions for Phase 1-4 trials.
Domain
Biotechnology / Clinical Development / Biostatistics
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, Expertise in end-of-phase meetings and advisory committees, Advanced degree in quantitative discipline
Technologies
SAS, R, CDISC standards, ICH guidelines, GCP
Responsibilities
Build and lead biostatistics, statistical programming, and clinical data management teams; Shape clinical data strategy and study designs for Phase 1-4 trials; Partner with clinical development, regulatory affairs, and medical writing; Oversee external consultants, vendors, and CROs; Ensure adherence to global regulatory standards; Advise stakeholders and the Board on quantitative methodologies.
Seniority
VP, Strategic & Hands-on