The successful Associate Director/Director, Biostatistics candidate will be responsible for developing and directing the statistical strategies, design and analyses for clinical trials in all phases of clinical studies and development compounds. Oversees and directs CRO activities, and serves as the statistical expert accountable for all statistical aspects of clinical studies and submission, including scientific validity, quality, and relevance from a regulatory perspective.
• Lead design, preparation and execution of statistical analysis plans (SAP) in support of clinical development programs, phase 1-3 and through NDA.
• Oversee and direct the execution of the SAP, preparation of the statistical methods and results sections for clinical study reports and overall summaries; this responsibility includes review of protocols and CRFs for soundness of trial design.
• Manage biostatistics resources, primarily CRO, timelines, milestones, and finances in relation to CRO management.
• Represent SAP, method, results, conclusions and inferences to regulatory agencies, health authorities or other external meetings.
• Serve as a primary source of scientific support for the research, design, analysis, reporting, and presentation of sophisticated statistical analysis and methods for phase 1-3 clinical studies and for nonclinical studies.
• Maintain strong knowledge of regulatory guidance including Good Clinical Practice, therapeutic area clinical guidelines, statistical guidelines, quality of life and patient reported outcomes.
• Develop SOPs to ensure compliance with GCPs related to clinical study conduct.
• Collaborates with Clinical, Development Operations, Translational Medicine, Regulatory, and Pharmaceutical Sciences and represents the Biostatistics function on the integrated project teams.