AD Biostatistics Oncology Medical Affairs-HEOR

Associate Director, Biostatistics Medical Affairs-HEOR

Location: Boston, MA or Remote (with periodic travel)
Employment Type: Full-time

Company Overview

I'm partnered with a commercial-stage biopharmaceutical organization they are uniquely positioned to pursue innovative science, focus on underserved patient populations, and make long-term, patient-centric strategic decisions. The organization has a strong and growing presence in oncology and is committed to advancing high-impact therapies.

Role Overview

The Associate Director, Biostatistics will play a critical, high-impact role within the Global Biometrics function, leading statistical strategy across Medical Affairs and Health Economics & Outcomes Research (HEOR) for oncology programs.

Operating as a senior individual contributor, this person will partner cross-functionally with Medical Affairs, HEOR, Clinical Development, and Regulatory teams to shape and execute evidence generation strategies across the product lifecycle. The role requires strong technical expertise combined with strategic thinking, particularly in Real-World Evidence (RWE), Health Technology Assessment (HTA), and payer-facing deliverables.

Key Responsibilities

• Lead statistical strategy supporting Medical Affairs and HEOR evidence generation across assigned oncology products
• Drive contributions to Integrated Evidence Generation Plans (IEGPs), Joint Scientific Consultations (JSC), and Joint Clinical Assessment (JCA) activities
• Provide statistical input into value dossiers and payer submissions, ensuring alignment with global HTA frameworks and market access requirements
• Identify evidence gaps and recommend innovative study designs and analytical approaches
• Serve as a statistical subject matter expert across:
  • Real-world evidence studies
  • Post-marketing and observational studies
  • Registry analyses
  • Indirect treatment comparisons (ITCs)
  • Patient-reported outcomes (PROs)
• Author and review statistical analysis plans (SAPs), including TLF specifications; oversee execution and ensure quality and interpretability
• Review protocols, clinical study reports, publications, and briefing documents for scientific and statistical rigor
• Represent Biostatistics on cross-functional teams, influencing key decisions through clear communication of statistical insights
• Support regulatory and payer interactions, including responses to statistical inquiries related to RWE and outcomes data
• Oversee CROs and external vendors to ensure quality, compliance, and methodological alignment
• Contribute to publication strategy through statistical review of abstracts, posters, and manuscripts
• Support continuous improvement of internal processes and quality standards within Biometrics

Qualifications

• PhD in Biostatistics, Statistics, or related field with 4+ years of industry experience
  (Master's degree with 8+ years of relevant experience will also be considered)
• Prior experience in oncology strongly preferred
• Deep expertise in:
  • Real-world evidence (RWE)
  • HEOR and post-approval studies
  • Indirect treatment comparisons and HTA submissions
• Strong knowledge of global regulatory and HTA frameworks (FDA, EMA, ICH, EU-HTA, ISPOR)
• Demonstrated experience contributing to regulatory or payer interactions
• Proficiency in SAS and/or R
• Proven ability to independently design studies and define analytical strategies
• Experience managing CROs and external vendors
• Strong communication skills with the ability to translate complex statistical concepts to non-technical stakeholders

Salary: $180-220,000 base, 20% bonus, + LTI + additional benefits