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. 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 of the Senior Director, Biostatistics include:

· 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.

Qualifications for the Senior Director, Biostatistics include:

· 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.

Compensation for the Senior Director, Biostatistics:

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

Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, 401K, and additional company-sponsored benefits.

This job opens for applications on 7/27/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: biostatistics, oncology, clinical research, clinical trials, FDA submissions, regulatory strategy, statistical analysis, Phase II, Phase III, health authority interactions, clinical development, CRO, biotechnology, pharmaceutical industry, audit readiness, inspection readiness, statistical programming, clinical study design, adaptive trials, sponsor management, executive leadership, people leadership, team management, forecasting, budgeting, resource planning, business operations, SAS, CDISC, clinical data analysis, regulatory compliance, stakeholder management, scientific leadership, trial methodology, drug development, global clinical operations, biometrics, project oversight, statistical consulting.

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