Job Description
The Director, Biostatistics, leads the full scope of statistical contribution to a clinical development program, including life cycle management. The Associate Director provides for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders.
Responsibilities and Accountabilities:
•Define the statistical strategy and ensure appropriate statistical methodologies applied to the clinical development plan, study design and data analysis for clinical trials, and regulatory submissions.
•Provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximize probability of program success.
•Interprets analysis results and ensures reporting accuracy in study reports and regulatory documents, abstracts...