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Director, Biostatistics

Servier Group

Boston (MA)

Hybrid

USD 120,000 - 180,000

Full time

27 days ago

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Job summary

An established industry player is seeking a strategic Director of Biostatistics to lead a global team focused on oncology products. This pivotal role involves overseeing the development of statistical methodologies to support Medical Affairs and Health Economics & Outcomes Research initiatives. The ideal candidate will have extensive experience in the pharmaceutical sector, particularly in oncology, and will play a key role in shaping evidence generation strategies throughout the product lifecycle. Join a forward-thinking organization committed to advancing science and improving patient outcomes in a collaborative environment.

Qualifications

  • 10+ years of experience in the pharmaceutical industry with leadership in Medical Affairs.
  • Expertise in statistical methodologies and oncology is essential.

Responsibilities

  • Lead a global team of biostatisticians in oncology research initiatives.
  • Collaborate on study designs and ensure regulatory compliance.

Skills

Statistical Leadership
Oncology Experience
Real-World Evidence
Collaboration Skills
Problem-Solving Skills
Communication Skills

Education

Ph.D. in Biostatistics or Statistics
MS with Extensive Experience

Tools

SAS
R
Python

Job description

Type of Contract: Full-time Employment / Unlimited

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

Servier is seeking a highly experienced and strategic Director, Biostatistics with strong oncology experience. This leadership role will oversee the development and implementation of robust statistical methodologies to support Medical Affairs and Health Economics & Outcomes Research (HEOR) initiatives for oncology products. The Director will manage a global team of biostatisticians, collaborate cross-functionally across Medical Affairs, HEOR, Clinical Development, and Regulatory, and play a critical role in shaping the evidence generation strategy across the product lifecycle. This individual will ensure the statistical integrity of Health Technology Assessment (HTA), observational studies, publications, health economics models, and medical strategy support. This individual may also work on clinical development projects.

Primary Responsibilities

  • Lead and mentor a global team of biostatisticians supporting Medical Affairs and HEOR across oncology assets.
  • Provide statistical leadership for HTA, post-marketing studies, retrospective analyses, registry studies, and patient-reported outcomes.
  • Collaborate with Medical Affairs to design and analyze studies that inform scientific communication, field medical engagement, and evidence dissemination.
  • Work closely with HEOR colleagues to support value dossiers, economic models, and payer submissions.
  • Partner with Clinical Development, Medical Directors, Epidemiology, Health Outcomes, and Data Science teams to align evidence strategy with broader organizational goals.
  • Represent Biostatistics in cross-functional medical teams and evidence generation working groups.
  • Provide strategic input on observational study protocols and ensure regulatory compliance with applicable guidance (e.g., FDA RWE guidance, ICH, EMA).
  • Support interpretation and presentation of study findings to internal stakeholders and external experts.
  • Contribute to regulatory and payer interactions, including submission of real-world evidence or outcomes-based data packages.
  • Lead or contribute to initiatives that enhance statistical methodology, data standards, and process efficiency in the post-marketing and HEOR space.
  • Stay current with industry trends, regulatory expectations, and methodological advances in Medical Affairs analytics and HEOR.
  • Provide statistical leadership for clinical development studies in a similar capacity to the role in Medical Affairs and HEOR, if assigned to such projects.

Education and Required Skills

  • Ph.D. in Biostatistics, Statistics, or related field (MS with extensive experience will be considered).
  • 10+ years of pharmaceutical industry experience, including significant oncology experience and preferably leadership within Medical Affairs and/or HEOR settings.
  • Demonstrated expertise in real-world evidence, observational study design, publication support, and health economics modeling, familiarity with HTA and post-approval study designs (e.g., FDA, EMA, ISPOR guidelines), and experience interacting with regulatory agencies and/or payers on biostatistical or HEOR matters are strongly preferred.
  • Strong programming skills in SAS; experience with R, Python, or visualization tools is a plus.
  • Proven leadership experience with a track record of managing and mentoring staff.
  • Exceptional collaboration, communication, and problem-solving skills.

Travel and Location

  • Some domestic and international travel may be required.
  • Boston hybrid preferred with 2-3 days/week in office; if fully remote, ability to travel to Boston.

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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