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.