Vice President, Biometrics

Braveheart Bio•San Francisco, CA

5d•Onsite

About The Position

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease. Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.

Requirements

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

Nice To Haves

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

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