senior director of biostatistics
We are supporting a growing biotechnology organization in identifying a seasoned Senior Director, Biostatistics to lead statistical strategy for late‑stage clinical development programs, with a particular focus on respiratory Phase 3 trials.
This is a strategic and hands‑on leadership position for someone who enjoys guiding clinical teams, shaping statistical direction, and partnering closely across Development, Regulatory, and Biometrics functions.
Key Responsibilities
- Lead statistical strategy and execution for late‑stage clinical programs, including Phase 3 respiratory studies.
- Oversee statistical deliverables across protocols, SAPs, interim analyses, and submission‑ready datasets and outputs.
- Serve as the primary statistical representative in cross‑functional teams and regulatory‑facing discussions.
- Provide statistical input into study design, including adaptive and other innovative methodologies.
- Ensure alignment across internal teams and external CRO partners, maintaining high‑quality and timely execution.
- Mentor and guide biostatisticians, supporting their technical growth and development.
Qualifications
- PhD in Statistics/Biostatistics with ~12+ years of industry experience, or MS with ~15+ years.
- Demonstrated leadership in respiratory clinical development, ideally with direct involvement in at least one Phase 3 respiratory trial
- Strong late‑stage development experience, including statistical ownership of Phase 3 programs.
- Hands‑on expertise with SAP authorship, CDISC standards, interim analyses, and DSMB support.
- Experience partnering with Regulatory Affairs and contributing to global submission activities.
- Proficiency in SAS and/or R.
- Prior experience managing or mentoring statisticians preferred.
Ideal Candidate Profile
You thrive in fast‑moving environments, communicate statistical concepts clearly, and enjoy working at the intersection of strategy, scientific rigor, and real‑world execution. You bring maturity in late‑phase program leadership and are comfortable steering statistical direction from design through submission readiness.