Associate Director Biostatistics

Apr; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking an Associate Director of Biostatistics to lead statistical efforts across clinical programs. This pivotal role involves collaborating with cross-functional teams to ensure data-driven decision-making in both early and late-stage clinical trials. The ideal candidate will possess a Ph.D. in Biostatistics and extensive industry experience, applying advanced statistical methods to support regulatory submissions. If you thrive in a fast-paced environment and are passionate about influencing clinical outcomes, this opportunity is perfect for you.

Qualifications

• 6+ years of industry experience with a Ph.D. or 8+ years with a Master’s.
• Strong foundation in clinical trial design and regulatory guidelines.

Responsibilities

• Lead statistical design and analysis for clinical studies.
• Draft statistical analysis plans and ensure quality of deliverables.

Skills

Analytical Thinking

Attention to Detail

Verbal Communication

Written Communication

Organizational Skills

Collaboration

Education

Ph.D. in Biostatistics

Master’s in Biostatistics

Tools

SAS

R

Job description

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Seeking an Associate Director of Biostatistics to provide statistical expertise and operational support across a variety of clinical activities with a focus on supporting early-stage and late-stage clinical programs. This role will serve as lead study statistician, collaborating with cross-functional teams to support clinical development and data-driven decision-making. The Associate Director will contribute hands-on to key deliverables, manage CROs, and provide guidance to junior team members.

Essential Responsibilities:

• Contribute to the statistical design and analysis of early and late phase clinical studies.
• Apply advanced statistical methods and data visualization skills to clinical trial data summaries and interpretations such as integrated safety and efficacy analyses for regulatory submissions.
• Serve as the biostatistics representative on cross-functional teams, ensuring alignment of statistical approaches with study and program objectives.
• Provide input on study design, endpoint selection, and sample size planning.
• Draft statistical analysis plans (SAPs) and support interpretation of results.
• Ensure the quality and accuracy of statistical deliverables by independently generating the statistical deliverables and/or independently reviewing and validating the statistical deliverables generated by either CRO or internal statistical programming team.
• Manage CROs and mentor junior staff or contractors as appropriate.

Education:

• Ph.D. in Biostatistics with 6+ years of relevant industry experience, or Master’s with 8+ years.

Experience:

• Strong foundation in clinical trial design, statistical analysis, and regulatory guidelines.
• Experience in publication work and/or analysis of real-world data preferred.
• Proficiency in statistical programming (SAS and R).
• Immunology or related therapeutic area experience a plus.
• Demonstrated ability to manage multiple priorities and work cross-functionally.
• Experience with both early-stage and late-phase clinical trials in biotech/pharmaceutical industry is preferred.

Skills:

• Strong analytical thinking and attention to detail.
• Excellent verbal and written communication skills.
• Ability to work independently in a fast-paced, regulated environment.
• Ability to manage deliverables with competing priorities and influence others effectively.
• Strong organizational skills, with the ability to manage workflows and activities to meet department timelines.
• Collaborative mindset and ability to influence without authority.

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