Associate Director Biostatistics

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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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