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A pharmaceutical development company in Reading is seeking a Principal Biostatistician to lead statistical planning and analysis for clinical trials. The successful candidate will work with cross-functional teams and ensure scientific integrity and regulatory compliance throughout the projects. This role involves preparing reports, developing protocols, and responding to regulatory queries.
As a Principal Biostatistician you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials.
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.