RoleStrategic VP, Biometrics leading biostatistics, statistical programming, analysis, and clinical data management across the full pipeline from IND-enabling studies to post-approval.
Responsibilitiesbuild and oversee high-performing teams
shape clinical data strategies
study designs
regulatory interactions for Phase 1-4 trials
partner with cross-functional teams and external vendors
ensure compliance with GCP, ICH, and CDISC standards
advise on quantitative methodologies for regulatory submissions
Requirements:
15+ years biotech/pharma leadership with 12+ years in biostatistics, extensive experience with NDAs/BLA submissions, advanced degree in biostatistics or related field, expert knowledge of ICH, GCP, CDISC; proven talent leadership.
HighValueclinical-stage biotech developing antibody-based medicines across endocrinology, women’s health, immunology, oncology; pipeline includes multiple drugs in clinical and preclinical phases, with emphasis on regulatory interactions and data strategy.
WorkSetupsenior leadership role, reporting to Chief Medical Officer, with a focus on collaboration and strategic oversight.
