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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.