Vice President, Biostatistics
Core
Enterprise-level strategic statistical leadership and oversight for global drug development programs, driving quantitative decision-making and regulatory strategy.
Role type
Vice President, Biostatistics (Strategic Leadership)
Builds
Global development programs for late-stage biotechnology therapeutics (ophthalmology, cystic fibrosis)
Domain
Biotechnology / Clinical Trials / Regulatory Affairs
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Strategic statistical leadership, CDISC standards (SDTM, ADaM), SAS programming, regulatory document development, team mentorship, CRO oversight
Preferred skills
Knowledge of novel endpoints and rare diseases, publication strategy, payor discussion preparation
Technologies
SAS, EAST, nQuery
Responsibilities
Provide executive-level leadership for study design, analysis, and health authority response; Lead cross-functional collaboration for drug development plans; Oversee CRO performance and study deliverables; Develop and review SOPs for process improvement; Shape team development and succession planning
Seniority
Executive, strategic leadership & mentorship