Vice President, Biometrics

The role:

The Vice President of Biometrics will provide strategic and operational leadership across statistical activities as the company transitions into Phase III clinical trials. This role will be responsible for defining and executing the integrated biometrics strategy, overseeing CRO and vendor partnerships, ensuring data integrity and regulatory readiness, and serving as a key leader on the clinical development team. The ideal candidate brings deep late-stage expertise, strong cross-functional leadership, and a hands-on mindset well suited for a lean, fast-growing biotech organization.

 

Key responsibilities:

• Provide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III execution
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth

 

Required experience & skills:

• Bachelor’s degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative discipline
• Minimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industry
• Significant experience leading biostatistics activities for Phase III clinical trials and regulatory submissions
• Demonstrated success managing CROs and external vendors in a late-stage development environment
• Proven track record as a strategic biometrics leader, contributing substantively to complex study designs, endpoint development, and statistical strategy across global development programs; able to provide sharp, on-your-feet thinking in real-time discussions with regulators, KOLs, and cross-functional teams, while maintaining a roll-up-your-sleeves approach to engage directly with protocols, analysis plans, and data when needed.
• Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readiness
• Proven ability to operate strategically while remaining hands-on in a lean organization
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

 

Preferred experience & skills:

• Prior experience serving as a functional or biometrics lead in regulatory interactions with FDA and ex-U.S. health authorities
• Experience in cardiovascular, rare disease, or genetically driven conditions
• Background in small or mid-sized biotech companies transitioning into late-stage development
• Experience building or scaling internal biometrics functions and infrastructure
• Familiarity with innovative trial designs and modern statistical methodologies

 

Base Salary Range: $300K - $375K

 

Develops therapies for hypertrophic cardiomyopathy and cardiovascular disease.