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Vice President, Head of Biometrics

About Climb:

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus, and CLYM116, an anti-APRIL monoclonal antibody in development for IgA nephropathy.

At Climb Bio, our team has a knack for seeing what no one else sees, and a drive to achieve results that no one expects. We believe that our combined strength conquers any summit, and our core values - Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment - guide how we work, collaborate, and innovate.They reflect our commitment to patients, each other, and the pursuit of transformative science.

We are seeking an experienced and strategic Vice President, Head of Biometrics to lead all biometrics activities across our clinical development programs. This individual will bring deep expertise in biostatistics, a track record of progressing from hands-on statistical leadership into broader biometrics management, and experience operating effectively in a lean biotechnology environment.

The VP, Head of Biometrics, will provide leadership across Biostatistics, Statistical Programming, and Data Management, overseeing a small team of internal and external resources while serving as the primary biometrics partner to Clinical Development leadership. This role will be highly cross-functional and hands-on, with responsibility for ensuring high-quality data, analyses, and biometrics deliverables that support clinical development and regulatory objectives.

Key Responsibilities:

• Lead the biometrics strategy across all clinical development programs.
• Serve as the lead statistician and biometrics representative on study teams.
• Provide statistical leadership for study design, endpoints, protocol development, sample size determination, and statistical analysis plans.
• Manage and mentor a team of internal and outsourced biometrics professionals.
• Oversee all biometrics activities, including biostatistics, statistical programming, and data management ensure high-quality, timely, and cost-effective execution, including documented oversight of data quality and integrity.
• Serve as the accountable owner of clinical trial data, ensuring systems are validated, controlled, and maintained in accordance with applicable regulations including 21 CFR Part 11, EU Annex 11, and ICH E6.
• Ensure sponsor oversight of CRO data management deliverables is documented and defensible.
• Review and interpret clinical data analyses and communicate findings to study teams and executive leadership.
• Support regulatory submissions and interactions with health authorities, including preparation and review of biometrics deliverables.
• Establish and maintain appropriate biometrics processes, standards, and quality practices (e.g., database governance, data transfer agreements/specifications and reconciliation).
• Partner closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure successful program execution.

Qualifications

• MS or PhD in Biostatistics, Statistics, or a related quantitative discipline.
• 12+ years of experience in the biotechnology or pharmaceutical industry, including substantial experience as a practicing biostatistician.
• Demonstrated progression into biometrics leadership with responsibility for biostatistics and broader biometrics functions.
• Experience overseeing Statistical Programming and Data Management activities.
• Proven success managing outsourced biometrics models and CRO partnerships.
• Experience supporting clinical studies through regulatory submissions and health authority interactions.
• Strong understanding of clinical trial design, statistical methodologies, CDISC standards, and clinical data workflows.
• Ability to operate both strategically and hands-on in a resource-conscious environment.
• Excellent communication, collaboration, and leadership skills.
• Demonstrated ownership of data integrity and GCP compliance for clinical data systems, including 21 CFR Part 11 and computerized system validation.
• Experience supporting health authority inspections or audits with direct responsibility for clinical data and biometrics documentation.
• Track record of establishing risk-based data quality and surveillance practices within a lean, outsourced operating model.

What Success Looks Like:

• Acts as the company's biometrics thought leader and trusted advisor to the CMO.
• Delivers high-quality biometrics support across all clinical programs through a combination of internal expertise and external partnerships.
• Build scalable, efficient biometrics capabilities appropriate for a growing biotechnology company.
• Ensures data integrity, statistical rigor, and regulatory readiness across the portfolio.
• Maintains an inspection-ready data and biometrics environment across the portfolio.

This position is a hybrid role based out of our Wellesley, MA office. Base salary offered may vary depending on the individual's skills, experience, and competitive market value.

• Salary Range: $305,000-$410,000

Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, Employee Stock Purchase Program, generous paid time off, and equity.

For more information, please visitclimbbio.com.

Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.