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Part-Time Biostatistics Consultant (Adaptive Design / PK Focus)

United States
$70-150 / hour

~20 Hours/Week

We are seeking a highly experienced biostatistical consultant to support a targeted therapy program in oncology, currently in pre-clinical to IND-enabling stages. This role will focus on studies where PK endpoints are critical to advancement, requiring strong expertise in adaptive study design and bioanalytical strategy.

This is a hands-on consulting opportunity suited for a biostatistician who thrives in early development environments and can operate independently while partnering cross-functionally.

Key Responsibilities

  • Provide statistical leadership for studies designed to generate PK data in support of IND filings
  • Lead and advise on adaptive study designs, including dose selection and optimization strategies
  • Support and interpret bioanalytical (BA) and bioequivalence (BE) data to inform development decisions
  • Contribute to study design, analysis planning, and data interpretation across non-clinical and early-phase development activities
  • Collaborate closely with clinical pharmacology, bioanalytical, and development teams to ensure alignment on study objectives and deliverables
  • Review and develop statistical input into protocols, analysis plans, and regulatory-facing documentation

 

Required Experience

  • Significant experience in biostatistics within drug development, with a strong emphasis on adaptive design methodologies
  • Deep expertise in PK-driven studies, particularly those supporting early development and IND-enabling work
  • Proven experience with bioanalytical (BA) and bioequivalence (BE) data and study interpretation
  • Background supporting oncology programs is preferred, though experience in PK-led development is prioritized
  • Prior experience in biotech or pharmaceutical environments
  • Ability to work autonomously in a part-time consulting capacity and navigate evolving program needs

 

Program Context

  • Focused on targeted oncology therapies with limited public visibility
  • Work will support progression toward IND filing rather than ongoing clinical trials
  • High-impact role influencing early development strategy and decision-making

 

Engagement Details

  • Part-time contract (~20 hours per week)
  • Initial term of 12–18 months
  • Flexible, remote working arrangement
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Discipline

Job Ref

CR/030261

Published

20 days ago

Expiry

19 Jun 2026 23:59

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