Vice President, Biostatistics
Cabaletta Bio
5 hours ago
Remote friendly (All, MO)
United States
Clinical Research and Development
Position: Vice President, Biostatistics (remote/hybrid; preference for Northeast)
Key Responsibilities
- Lead and develop the Biostatistics and Data Management functions; create long-term vision, operating model, and high-performance culture.
- Recruit, mentor, and inspire the team to scale organizational capability with the clinical portfolio.
- Advise executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making.
- Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection.
- Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate timelines and strengthen robustness of findings.
- Ensure statistical strategies align with regulatory expectations for submissions, inspections, and commercial planning.
- Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for clinical studies.
- Ensure integrity, quality, reproducibility, validation, and submission-ready documentation of statistical analyses.
- Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and others for seamless execution and data-driven decisions.
- Lead statistical aspects of regulatory interactions/submissions (e.g., BLAs, briefing packages, responses, advisory committee materials); late-stage experience strongly preferred.
- Represent the company in regulatory meetings and ensure alignment with global regulatory standards and evolving guidance.
- Oversee CROs, data vendors, and technology platforms for high-quality, on-time, compliant deliverables.
- Champion modern data management and statistical computing practices (scale, audit readiness, efficiency).
- Stay current on statistical methodologies, regulatory trends, and industry best practices.
Qualifications / Required
- PhD or Master’s degree in Biostatistics, Statistics, or related field.
- 10+ years of relevant biotech/pharmaceutical R&D experience, including leadership of statistical strategy for early and late-stage clinical programs.
Preferred / Leadership & Strategic Impact
- 7+ years leading Biostatistics teams (statisticians, programmers, and/or data management).
- Demonstrated success shaping statistical strategy for pivotal trials and regulatory submissions.
- Strong track record with late-stage development/regulatory submissions; BLA experience strongly preferred.
- Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness.
- Exceptional communication skills translating complex concepts for diverse audiences.
- Experience managing departmental budgets, vendor relationships, and technical infrastructure.
Benefits (if explicitly stated)
- Competitive benefits, PTO, and stock option plans.
Application Instructions
- Apply via Cabaletta Bio’s careers page: https://www.cabalettabio.com/join-our-crew
Key Responsibilities
- Lead and develop the Biostatistics and Data Management functions; create long-term vision, operating model, and high-performance culture.
- Recruit, mentor, and inspire the team to scale organizational capability with the clinical portfolio.
- Advise executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making.
- Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection.
- Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate timelines and strengthen robustness of findings.
- Ensure statistical strategies align with regulatory expectations for submissions, inspections, and commercial planning.
- Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for clinical studies.
- Ensure integrity, quality, reproducibility, validation, and submission-ready documentation of statistical analyses.
- Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and others for seamless execution and data-driven decisions.
- Lead statistical aspects of regulatory interactions/submissions (e.g., BLAs, briefing packages, responses, advisory committee materials); late-stage experience strongly preferred.
- Represent the company in regulatory meetings and ensure alignment with global regulatory standards and evolving guidance.
- Oversee CROs, data vendors, and technology platforms for high-quality, on-time, compliant deliverables.
- Champion modern data management and statistical computing practices (scale, audit readiness, efficiency).
- Stay current on statistical methodologies, regulatory trends, and industry best practices.
Qualifications / Required
- PhD or Master’s degree in Biostatistics, Statistics, or related field.
- 10+ years of relevant biotech/pharmaceutical R&D experience, including leadership of statistical strategy for early and late-stage clinical programs.
Preferred / Leadership & Strategic Impact
- 7+ years leading Biostatistics teams (statisticians, programmers, and/or data management).
- Demonstrated success shaping statistical strategy for pivotal trials and regulatory submissions.
- Strong track record with late-stage development/regulatory submissions; BLA experience strongly preferred.
- Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness.
- Exceptional communication skills translating complex concepts for diverse audiences.
- Experience managing departmental budgets, vendor relationships, and technical infrastructure.
Benefits (if explicitly stated)
- Competitive benefits, PTO, and stock option plans.
Application Instructions
- Apply via Cabaletta Bio’s careers page: https://www.cabalettabio.com/join-our-crew