Vice President, Biostatistics Job at Cabaletta Bio Inc (Philadelphia)

Job Description

The Vice President, Biostatistics is a key enterprise leader responsible for setting the strategic direction, vision, and executional rigor of the company’s biostatistics and data management capabilities. Reporting to the VP, Clinical Development, this leader will serve as the principal statistical authority across the organization—guiding program strategy, influencing portfolio decisions, and ensuring statistical excellence from early development through registration-stage programs. This role requires deep expertise in statistical methodologies, strong scientific judgment, and the ability to anticipate what is required to advance complex clinical programs in a dynamic environment. The ideal candidate will balance scientific rigor with operational pragmatism, provide leadership across functions, and communicate effectively with executive leaders, scientific teams, regulators, and external partners. As a senior leader in a fast-paced, growing company, the VP will also be instrumental in building organizational capability, advancing operational excellence, and fostering a high-performing, collaborative culture aligned with our values.

Job Responsibility

Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture
Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio
Serve as a strategic advisor to 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 to optimize probability of technical and regulatory success
Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings
Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning
Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies
Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation
Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making
Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials
Represent the company in regulatory meetings as needed and ensure alignment with global regulatory standards and evolving guidance
Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards
Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency
Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation

Requirements

PhD or Master’s degree in Biostatistics, Statistics, or related field
10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs
At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups
Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions
Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams
Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred
Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness
Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences
Experience managing departmental budgets, vendor relationships, and technical infrastructure
Highly collaborative, with strong interpersonal skills and the ability to build trust across teams
Strategic thinker with strong scientific rigor and operational pragmatism
Thrives in a fast-paced, evolving environment
able to manage multiple priorities with clarity and focus
Demonstrates integrity, accountability, and a commitment to continuous learning and team development
Comfortable with hands-on leadership in a small-company environment

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