Job Details

Director / Sr. Director, Biostatistics

Location: Hybrid – Onsite 3+ days/week | Clinical-Stage Biotech

A clinical-stage biotech company is hiring a Director or Sr. Director of Biostatistics to lead biostatistical strategy across oncology, immunology, and inflammation programs. This role will drive study design, regulatory submissions, and vendor oversight while collaborating closely with cross-functional teams.

Responsibilities:

• Lead biostatistics and programming for global clinical trials
• Define and uphold statistical standards; review SAPs, protocols, CSRs, CDISC/ADaM datasets
• Oversee CROs and vendors to ensure quality and timely deliverables
• Contribute to regulatory strategy and submission planning
• Build and mentor a high-performing biometrics team

Qualifications:

• PhD in Biostatistics (MS considered with strong experience)
• 10+ years in clinical biostatistics (biotech/pharma/CRO)
• Expertise in clinical trial design, FDA/EMA guidelines, and SAS
• Proven experience with regulatory submissions and CRO oversight
• Strong leadership and cross-functional collaboration skills