Vice President, Biometrics

Vice President, Biometrics

About the Company

Innovative biotechnology company developing durable gene therapies for chronic diseases

Industry
Biotechnology

Type
Privately Held, VC-backed

Founded
2019

Employees
51-200

Specialties

• gene therapy

About the Role

The Company is seeking a 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 health authority interactions, overseeing data standards and programming, supporting long-term safety monitoring, and managing CROs and technology vendors. The VP will also build and develop a scalable team, maintain inspection readiness, and partner with clinical, regulatory, safety, operations, and other functions. 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 12 years of industry biometrics experience, including five or more years leading teams or functions, and a record of contributing to successful regulatory submissions and approvals. Deep knowledge of CDISC standards, ICH guidelines, FDA and EMA expectations, trial design, and regulatory interactions is required, along with proficiency in SAS, R, and clinical data standards and systems. Experience in gene therapy, rare disease, or other complex clinical programs, as well as CRO oversight, team building, and clear executive communication, is strongly valued.

Hiring Manager Title
Chief Medical Officer

Functions

• Data Management/Analytics