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Director/Sr. Director, Biostatistics

Philadelphia, PA

About the Position

The Senior Director of Biostatistics is responsible for overseeing the statistical aspects of clinical research programs for the company. The Senior Director of Biostatistics must have a deep understanding of statistical methodologies and their application to clinical trials, as well as a strong business acumen to effectively manage resources, timelines, and budgets. The role requires strong interpersonal skills and the ability to effectively communicate with both technical and non-technical stakeholders.

Responsibilities Include

  • Build and lead the Biostatistics and Data Management functions within the organization, managing a team of statisticians, programmers, and data managers to ensure the timely and accurate delivery of statistical outputs for clinical studies.
  • Develop statistical analysis plans and oversee the implementation of statistical methodologies for clinical studies, ensuring their compliance with regulatory guidelines and data management standards for regulatory inspections and/or submissions.
  • Provide strategic input to study design, protocol development, and clinical development plans to ensure optimal study designs and efficient use of resources.
  • Collaborate with cross-functional teams including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and medical affairs to ensure the successful execution of clinical trials.
  • Ensure that all statistical analyses are of high quality and are appropriately documented, and that the conclusions drawn from the analyses are supported by the data.
  • Provide statistical support for regulatory submissions, including authoring and reviewing statistical sections of regulatory documents.
  • Ensure compliance with applicable regulatory guidelines, industry standards, and company policies.
  • Manage departmental resources, including budget, personnel, vendor oversight, and technology infrastructure, to ensure the delivery of high-quality statistical input.
  • Develop and maintain relationships with key external stakeholders, including regulatory agencies, academic institutions, contract research organizations, vendors and other industry organizations.

Required Qualifications

  • PhD or master’s degree in Biostatistics or related field and 10+ years related work experience.
  • At least 7 years of experience in the pharmaceutical/biotech industry or clinical research organization in the design/analysis of early- and registration-stage programs
  • Proven track record of successful leadership in Biostatistics, with experience managing teams of statisticians and data managers.
  • Strong knowledge of statistical methodologies and their application to clinical research.
  • Excellent communication, leadership, and interpersonal skills.
  • Demonstrated ability to work effectively with cross-functional teams.
  • Track record of successful regulatory submissions, including deep knowledge of regulatory guidelines and industry standards.
  • Strong business acumen, with experience managing budgets and resources.
  • Strong team orientation and passion for continuous self-development.
  • Excellent leadership and organizational skills, highly collaborative and supportive, attention to detail, time management, and flexible attitude with respect to work assignments
  • Embraces new learning and demonstrates strong ability to communicate and interact in a team environment.
  • Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.

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How to Apply

Please click the link at the bottom of the posting to submit an application.


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

Equal Opportunity Employer

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.