Senior Director of Biostatistics

Piper Companies is seeking a Senior Director of Biostatistics to join a global clinical research and drug development organization for a hybrid permanent position based out of Raleigh, NC.

About the role

The Senior Director, Biostatistics will serve as the functional Head of Biostatistics, providing strategic leadership across late-stage clinical development programs while partnering with sponsors, regulatory agencies, and cross-functional teams to drive high-quality statistical deliverables and business growth.

Responsibilities

• Serve as the primary statistical leader for sponsor engagements, providing strategic consultation to executive stakeholders and clinical development leadership teams.
• Guide statistical strategy for Phase II and Phase III clinical trials, including regulatory submission planning, interactions with health authorities, and review of key submission deliverables.
• Oversee inspection and audit readiness activities, ensuring biostatistics processes, documentation, and outputs meet regulatory and quality expectations.
• Provide scientific leadership on advanced statistical methodologies, innovative trial designs, and complex clinical development programs, with a strong emphasis on oncology studies.
• Lead and mentor a team of biostatistics professionals while maintaining oversight of departmental budgets, resource planning, and operational performance.

Requirements

• Advanced degree (PhD preferred) in Biostatistics, Statistics, Mathematics, or a related quantitative discipline.
• Significant leadership experience within a CRO, biotechnology, or pharmaceutical environment, including direct people management responsibilities.
• Demonstrated success supporting FDA and global regulatory submissions for Phase II and Phase III clinical development programs.
• Strong background in oncology clinical trials with exposure across multiple therapeutic areas.
• Proven ability to develop trusted client relationships, influence senior stakeholders, and drive strategic business partnerships.

Pay

Salary Range: $260,000-$285,000/year (USD)

Benefits

• Medical, Dental, Vision
• Sick leave if required by law
• 401K
• Additional company-sponsored benefits