Director Biostatistics

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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

• Seniority level Director

• Employment type
  
  Full-time

• Job function
  
  Research and Science
• Industries Research Services and Hospitals and Health Care

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Medical insurance

401(k)

Paid maternity leave

Vision insurance

Pension plan

Child care support

Paid paternity leave

Student loan assistance

Disability insurance

Tuition assistance

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