Senior Director, Biostatistics - Oncology

Location: Pennsylvania
Department: Biostatistics
Reports to: VP/Head of Biostatistics

Position Summary

The Senior Director, Biostatistics - Oncology will serve as a strategic leader responsible for driving statistical excellence across the oncology portfolio. This role provides scientific and operational leadership for clinical trial design, statistical methodology, regulatory strategy, data interpretation, and cross‑functional decision‑making. The Senior Director will oversee large-scale oncology programs (early and/or late phase), manage high-performing biostatistics teams, and partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Medical Affairs, and Data Management.

This is a highly visible role that requires deep oncology expertise, strong communication skills, and a proven ability to influence scientific and business strategy in a dynamic, fast-paced environment.

Key Responsibilities

Strategic Leadership

• Lead statistical strategy for the oncology portfolio, including clinical development planning, study design, and regulatory interactions.
• Serve as a key statistical expert and thought leader across the organization, ensuring integrated, data-driven strategic decisions.
• Provide expert guidance on innovative statistical methodologies including adaptive designs, Bayesian methods, enrichment designs, real-world evidence, and biomarker-based strategies.

Clinical Development & Trial Execution

• Lead statistical input for Phase I-IV oncology trials, including protocol development, SAPs, sample size estimation, endpoint selection, and randomization strategies.
• Drive statistical oversight throughout the trial lifecycle, ensuring high-quality deliverables for interim analyses, database locks, and CSRs.
• Ensure statistical accuracy and consistency across multiple studies and indications.

Regulatory & Compliance

• Represent the company in statistical discussions with FDA, EMA, and other global health authorities.
• Prepare and review statistical content for regulatory submissions including INDs, BLAs, NDAs, S/NDAs, briefing packages, and responses to regulatory queries.
• Ensure compliance with global statistical and clinical regulatory guidelines (ICH, GCP, FDA guidance).

Cross-Functional Collaboration

• Partner with Clinical Development, Biometrics, Data Science, Translational Medicine, and Safety to support integrated data analyses and decision‑making.
• Collaborate closely with KOLs, external statisticians, CROs, and academic partners.
• Contribute to scientific publications, abstracts, conference presentations, and internal decision documents.

Team Leadership & Management

• Lead and mentor a team of biostatisticians and statistical programmers.
• Build a culture of scientific excellence, innovation, accountability, and continuous improvement.
• Prioritize resources and ensure scalable processes, standards, and tools across the function.

Qualifications

Education

• PhD in Biostatistics, Statistics, or a related quantitative discipline required.

Experience Required

• 12+ years of biostatistics experience within the pharmaceutical, biotech
• Extensive oncology experience required (solid tumors and/or hematological malignancies).
• Proven leadership in late-stage development and regulatory submissions strongly preferred.
• Demonstrated experience interacting with global regulatory agencies.

Technical Skills

• Deep expertise in clinical trial methodology, including innovative and adaptive designs.
• Strong proficiency in SAS; knowledge of R preferred.
• Familiarity with CDISC standards (SDTM, ADaM).
• Experience with survival analysis, longitudinal data analysis, and complex oncology endpoints (ORR, PFS, OS, MRD, biomarkers).

Leadership & Communication

• Exceptional ability to influence at all levels, including executive leadership.
• Excellent scientific writing and presentation skills.
• Strong people-management experience, with the ability to mentor and grow teams.

Additional Attributes

• Strategic thinker with strong business acumen.
• Thrives in a fast-paced, evolving environment.
• Passion for advancing oncology therapies and making an impact in patients' lives.
• Collaborative, proactive, and solutions-oriented mindset.