Vice President, Biometrics

Braveheart Bio

Vice President of Biometrics leading strategic and operational activities for clinical trials at Braveheart Bio. Overseeing CRO partnerships and ensuring regulatory compliance in late-stage development.

Posted 5/8/2026full-timeSan Francisco • California • 🇺🇸 United StatesLead💰 $300,000 - $375,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) matching
Paid time off
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

biostatisticsstatistical analysisclinical trial designdata qualityregulatory submissionssample size calculationsadaptive trial methodologiesstatistical programmingdata integrityGCP compliance

Soft Skills

strategic leadershipcollaborative approachstrong communication skillsmentoringproblem-solvingadaptabilityteam-orientedhands-on mindsetcritical thinkingflexibility