Senior Vice President, Biometrics Remote (anywhere in United States)
About the Role
Remote (anywhere in United States)(United States)
The Company is seeking a Senior Vice President of Biometrics to lead biostatistics, statistical programming, and clinical data management across its clinical pipeline. The role will set the biometrics strategy and operating model, guide trial design and statistical analyses, and ensure high-quality, submission-ready data. Responsibilities include leading regulatory biometrics strategy and health authority interactions, overseeing data standards and systems, and supporting long-term safety follow-up. The SVP will also manage CRO and vendor relationships, maintain compliance and inspection readiness, and build a scalable team and organization. Candidates must have a PhD in Biostatistics, Statistics, or a related quantitative field; an MS may be considered with exceptional experience. They should bring at least 15 years of industry biometrics experience, including seven or more years leading biometrics organizations, and a record of supporting successful regulatory submissions and approvals. Deep knowledge of CDISC standards, ICH guidelines, regulatory expectations, and statistical methods for novel and adaptive designs is required, along with proficiency in SAS, R, and clinical data standards. Experience in cell or gene therapy, rare disease, or relevant therapeutic areas, as well as strong leadership, communication, collaboration, and team-building skills, is preferred.
Functions:
- Data Management/Analytics
- Business Development
About the Company
Innovative biotechnology company developing durable gene therapies for chronic diseases
Industry
Biotechnology
Type
Privately Held, VC-backed
Age
employees
51-200