Serving as the primary contact within the customer for trial progress and governance. Developing study management plans and further documents for complex phase I and phase II trials (including authoring trial protocol and protocol synopsis, ICF, integrated Quality plan, etc.).
Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.