Director of Biostatistics - Remote, Biotech

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Contract Term: 18 months (with potential for full-time hire)

A clinical-stage precision oncology company is seeking a Director of Biostatistics for an 18-month contract role to lead biostatistical strategy and execution across clinical development programs. This role may convert to a full-time position based on performance and organizational needs.

About the Company

This company is a publicly traded biotech focused on developing targeted cancer therapeutics. The organization applies a precision medicine approach, leveraging translational biomarkers and synthetic lethality to deliver therapies tailored to specific patient populations. It has established strategic collaborations with leading pharmaceutical companies and wholly owns its most advanced clinical programs.

Position Summary

The Director of Biostatistics will provide strategic and operational leadership in the planning and execution of clinical trials and regulatory submissions. Working closely with cross-functional teams—Clinical Development, Regulatory Affairs, Drug Safety, and others—this leader will ensure high-quality, timely statistical deliverables and uphold rigorous statistical standards across programs.

Key Responsibilities

• Lead and manage cross-functional biostatistics support for clinical programs, ensuring alignment with development strategy.
• Provide strategic input on study design, clinical development plans, and regulatory strategy.
• Oversee authoring, review, and approval of key documents such as protocols, SAPs, CRFs, CSRs, and regulatory filings.
• Manage internal and external biostatistics teams, including contractors, CROs, and statistical programmers.
• Serve as a statistical expert to internal teams and external stakeholders including regulatory authorities and KOLs.
• Translate scientific and clinical questions into statistical methodologies and ensure their effective communication across teams.
• Remain current with statistical methodologies, clinical trial design best practices, and regulatory expectations.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related field.
• 12+ years of industry experience in biostatistics for drug development, with at least 8 years in oncology.
• Demonstrated expertise in clinical trial design, especially in time-to-event analyses and adaptive trial methods.
• Hands-on experience supporting all phases of oncology clinical trials, including NDA/BLA submissions.
• Proven leadership in cross-functional drug development environments.
• Strong communication skills and ability to mentor, manage, and collaborate with internal and external teams.

• Seniority level Director

• Employment type
  
  Contract

• Job function Science
• Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

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