Director, Biostatistics

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Full-time Employment / Unlimited

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About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting‑edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision.

Role Summary

As a strategic leader within the Global Biometrics Department, the Director, Biostatistics leads the development and implementation of statistical solutions in clinical trials, evidence generation, and decision making. This role will lead the statistical strategy for assigned clinical development products or evidence generation across our portfolio and may supervise statisticians both in‑house and at CROs, ensuring timely and high‑quality biostatistics deliverables.

In addition, this individual may independently represent Biostatistics in interactions with regulatory authorities or the external scientific community.

Primary Responsibilities

Strategic Ownership & Leadership

• Act as the biostatistics expert and leader, serve as primary statistical representative for cross‑functional teams, including clinical, evidence generation, and asset teams, and communicate plans and strategy to subordinates
• Lead a small team of Biostatisticians, supporting talent acquisition, career development, retention, and resourcing needs in partnership with department leadership, mentor junior biostatisticians in project teams
• Provide strategic statistical leadership and oversight for multiple assets or indications. Accountable for the quality and timeline of statistical deliverables, including design, analyses, and interpretation of results.
• Advocate for resource allocation and ensure efficient utilization of available capacity, optimizing project outcomes and enhancing operational efficiency
• Propose and advocate for innovative designs and decision‑making tools for product development or other evidence generation strategies
• Lead the evaluation and adoption of appropriate statistical methodologies for design and analysis to optimize study efficiency and increase the probability of technical success.
• Proactively identify potential statistical risks and develop robust contingency plans to ensure integrity and meeting project milestones.
• Influence and lead departmental process improvement initiatives and the development and revision of quality documents

Regulatory & Scientific Accountability

• Responsible for interacting with regulatory authorities, other external bodies or scientific community on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
• Responsible for the statistical aspects of regulatory documents such as protocols, investigator brochures, study reports, and submission packages as well as integrated reports and summary documents
• Oversee the publication strategy by reviewing and approving abstracts, posters, and manuscripts
• Monitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in compliance
• Develop and standardize key Biostatistics documentation (e.g., statistical sections of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings)

Education and Required Skills

• Ph.D. in Biostatistics or closely related field is required with a minimum of 9 years of relevant pharmaceutical experience. Master’s degree in Biostatistics or related field may be considered with a minimum of 12 years of relevant pharmaceutical experience
• Broad knowledge and superior…