Vice President, Biometrics
$311,000–$360,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Define the strategic vision for the Biometrics function and lead an internal team of biostatisticians and statistical programmers. Oversee the design and execution of Phase 1–3 clinical trials, including sample size determination, adaptive design methodology, and endpoint strategy. Author and review Statistical Analysis Plans, protocols, and clinical study reports to ensure regulatory compliance with FDA, EMA, and global health authorities. Establish and scale biometrics infrastructure, including vendor strategy, processes, and CDISC-compliant data standards. Lead contributions to INDs, NDAs, and BLAs while representing the company in regulatory meetings. Manage CRO and biometrics vendor contracts, budgets, and performance oversight. Represent Biometrics at governance committees and executive leadership meetings to support data-driven decision-making across the organization.
Required Qualifications
- PhD, MS, or equivalent advanced degree in Biostatistics, Statistics, or a closely related quantitative field
- Minimum of 12 years of experience in biometrics within the pharmaceutical or biopharmaceutical industry
- At least 5 years in a senior leadership role overseeing biostatistics, programming, and/or data management
- Demonstrated success leading biometrics for at least one NDA, BLA, or equivalent global regulatory submission resulting in approval
- Deep expertise in clinical trial design (including adaptive designs), statistical methodology, and regulatory statistics (ICH E9, E9(R1), E8)
- Extensive experience with CDISC standards (CDASH, SDTM, ADaM) and regulatory submission requirements
- Proven track record building and leading high-performing biometrics teams, internally and through CRO partnerships
- Strong experience with FDA, EMA, and global health authority interactions on statistical matters
- Proficiency in SAS
- Exceptional communication skills with the ability to translate complex statistical concepts for non-statistical audiences
Desired Qualifications
- Experience with R and other programming languages
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