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About the Role

The Vice President and Head of Biometrics will lead the Biometrics organization, defining and executing the company’s integrated biometrics strategy across all clinical development programs. This role involves leading the internal biometrics team, overseeing external partners, and ensuring high-quality, submission-ready deliverables for global regulatory filings. The ideal candidate possesses deep late-stage expertise, strong cross-functional leadership, and a hands-on approach suitable for a lean, fast-growing biotech company.

Responsibilities

Provide strategic and operational leadership for the entire Biometrics organization, including Biostatistics, Statistical Programming, and Data Management across all clinical development programs, with primary focus on Phase III execution
Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth
Define and execute an integrated biometrics strategy across all clinical development programs from Phase 2 through registration
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 to proactively identify risks and support development decisions
Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities
Drive organizational planning, hiring, mentoring, succession planning, and capability development across the Biometrics function
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

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
Experience leading multidisciplinary Biometrics organizations encompassing Biostatistics, Statistical Programming, and Data Management
Demonstrated success building, mentoring, and developing high-performing biometrics teams in a growing biotechnology organization
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
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
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

Skills

Biostatistics
Statistical Programming
Data Management
Clinical trial design
Data quality
Statistical analysis
Regulatory submissions
GCP
ICH
Global regulatory requirements
Study design
Endpoint selection
Sample size calculations
Adaptive trial methodologies
Innovative trial methodologies
Regulatory interactions
Inspection readiness
Written communication
Verbal communication
Collaboration
Team-oriented approach
Strategic thinking
Hands-on approach

Experience Level

12+ years of progressive experience in biostatistics

Education Level

Bachelor’s degree or advanced degree in biostatistics, statistics, mathematics, or a related quantitative discipline

Salary/Compensations

$300K - $375K

Benefits

Annual bonus
Equity
Comprehensive benefits offering

About the Company

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases.
Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM).
Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.
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.

Equal Opportunity

We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Braveheart participates in the federal E‑Verify program to confirm employment authorization for all new hires.