Associate Director, Biostatistics, Clinical Late Stage

The Opportunity:

This position serves as a study level statistician for oncology studies in clinical late-stage development and provides leadership across biostatistical activities. The Associate Director will collaborate across functions and contribute to program-level decision-making.  

• Represent biostatistics on study and cross-functional project teams, providing statistical leadership.

• Lead and manage biostatistical activities to ensure consistency, scientific rigor, and timely deliverables.

• Provide statistical expertise for design, analysis and reporting of clinical studies.

• Develop statistical analysis plans and analysis specifications; ensure analyses align with clinical and regulatory objectives.

• Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications and delivered with high quality.

• Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.

• Provide statistical input to the development of global health authority documents, regulatory interaction, and response to health authority submissions.

• Influence strategy and inform decision-making through data-driven insights and clear communication of risk and benefit.

• Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation.

• Contribute to the development of functional-level standards, SOPs, and templates.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Hands-on experience in design and analysis of late-stage oncology trials is a must.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Hands-on experience in design and analysis of phase 3 oncology trials is desirable.

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