Director Biostatistics

Head of Biostatistics (Contract | Remote | Potential to Go Permanent)

Remote| Minimal travel (quarterly or less) - USA

We are seeking an accomplished Head of Biostatistics to lead statistical strategy across early to late-stage clinical development programs. This senior role will drive study design, statistical methodologies, and regulatory-facing deliverables that support asset progression and approvals.

This is a contract position with scope to transition to a permanent role , offering flexibility, influence, and visibility across the development pipeline.

Key Responsibilities

• Lead biostatistical strategy across multiple clinical programs
• Oversee study design, statistical analysis plans, and key regulatory deliverables
• Provide expert statistical input into clinical protocols, study reports, and submissions
• Partner cross-functionally with Clinical Development, Regulatory, and Operations teams
• Manage CROs and external vendors
• Represent biostatistics in interactions with global health authorities
• Mentor and develop biostatistics team members

Experience & Background

• PhD in Statistics/Biostatistics with 10+ years industry experience, or MS with 15+ years
• Proven leadership of late-stage clinical trials and regulatory submissions
• Experience in neurology/neuroscience trials strongly preferred
• Deep knowledge of ICH/FDA/EMA guidelines and clinical trial methodologies
• Proficiency with SAS and/or R
• Strong communicator able to translate complex data into clear insights

Interested in a senior, remote leadership role with long-term potential?

Apply or reach out directly to me at:

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