Director of Biostatistics

Are you ready to make a meaningful impact in the world of biostatistics and clinical development? We are seeking a dynamic Director of Biostatistics to provide leadership and expertise across critical clinical programs, collaborating with cross-functional teams to deliver high-quality results that drive groundbreaking therapies.

Key Responsibilities

• Serve as the statistical leader and expert on clinical program teams, offering strategic direction and guidance.
• Lead statistical discussions with external stakeholders , including Health Authorities and development partners.
• Contribute statistical insights to essential clinical documents such as Regulatory Briefing Documents and Investigator Brochures.
• Collaborate with internal teams and CROs to:
• Develop clinical protocols.
• Author statistical analysis plans and TLF templates.
• Design analysis specifications, CRFs, and CRF edit checks.
• Conduct data analysis, interpret study results, and work with clinical teams on interim reviews, final reports, and publications.
• Oversee publication efforts and support ongoing tasks.
• Supervise and ensure the delivery of high-quality work from FSP and CRO biostatistics teams, staying within budget and timelines.
• Mentor and manage junior statisticians, fostering growth and expertise within the team.

Qualifications

• Advanced degree (MS/MA with 12+ years or PhD with 8+ years) in a related field.
• Experience in the pharmaceutical/biotechnology industry , with a preference for oncology experience.
• Strong knowledge of CDISC standards and SAS programming .
• Familiarity with relevant regulations, industry standards, and guidance documents .
• Exceptional communication, collaboration, and problem-solving skills.

Why Join Us?

We believe our people are our greatest asset, and we are committed to supporting their well-being. Our comprehensive compensation and benefits package reflects this philosophy.

• Compensation: Base salary range of $245,000–$260,000, with placement based on experience. Annual performance-based bonus and equity (RSU) grant included. Relocation assistance available if needed.
• Benefits:
• 100% coverage for medical, dental, and vision for employees and dependents.
• Unlimited vacation and a 3-day weekend every month.
• Fully paid parental leave (up to 6 months).
• Tuition reimbursement and a 401(k) employer contribution.

If you're passionate about advancing the future of healthcare and shaping life-changing therapies, we’d love to hear from you.