Director Biostatistics Oncology

We have a current opportunity for a Director Biostatistics Oncology on a permanent basis. The position will be based in Boston, MA. For further information about this position please apply.

Job Title: Director, Biostatistics - Oncology (Leadership Role)

Location: Greater Boston, MA | Remote

Reports to: Senior Director Biostatistics
Job Type: Full-Time | Hybrid/Remote Options Available

Salary: $220-260,000 base salary, 25% bonus + additional benefits

Position Summary:

We are seeking a highly experienced and strategic Director of Biostatistics. 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.

Key Responsibilities:

• Strategic Leadership:

  • Lead and mentor a global team of biostatisticians supporting Medical Affairs and HEOR across oncology assets.
  • 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.
  • Provide strategic input on observational study protocols and ensure regulatory compliance with applicable guidance (e.g., FDA RWE guidance, ICH, EMA).

• Study Design & Analysis:

  • Provide statistical expertise in the design of clinical trials, including adaptive designs, Bayesian methods, and innovative endpoints.
  • Oversee statistical analysis plans (SAPs), interim analyses, and final study reports.

• Regulatory Interactions:

  • Represent Biostatistics in regulatory meetings (e.g., FDA, EMA), including preparation of briefing documents and responses to regulatory queries.
  • Ensure compliance with ICH guidelines, GCP, and regulatory requirements.

• Team Management:

  • Will lead 3 direct reports

• Vendor Oversight:

  • Manage and review work performed by CROs and external vendors to ensure quality and consistency.

Qualifications:

• Ph.D. Statistics/Biostatistics
• 8+ years of experience in the pharmaceutical/biotech industry, with a strong focus on oncology clinical trials (5 years mimimum).
• Proven track record of leading statistical strategy for successful regulatory submissions (NDA/BLA/MAA).
• Deep understanding of statistical methodologies relevant to oncology, including survival analysis, longitudinal data, and biomarker-driven designs.
• Excellent communication and leadership skills, with the ability to influence across functions and levels.

Preferred Qualifications:

• Experience with immuno-oncology, precision medicine, or cell/gene therapy.
• Familiarity with CDISC standards (SDTM, ADaM) and programming in SAS or R.
• Prior experience managing global teams or working in a matrixed environment.

Why Join Us?

• Be part of a mission-driven organization advancing cutting-edge oncology therapies.
• Collaborate with world-class scientists and clinicians.
• Competitive compensation, equity, and benefits package.
• Opportunities for professional growth and leadership development.