Vice President, Biostatistics

Remote

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

 

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

 

Position Description:               

 

This role can be based out of our Philadelphia, PA headquarters, hybrid, or remote (strong preference for candidates based in the Northeast). 

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.

Key Responsibilities:

  • 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.  Late stage development experience is strongly preferred.
  • 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.

 

Qualifications:

  • 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.

Leadership & Strategic Impact

  • 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.

 

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

 

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