Job Description
The Clinical Development Statistician Lead is responsible for defining the statistical approach to clinical program designs and supporting the execution of clinical trial strategy. The role designs, coordinates, and supervises statistical aspects of clinical research activities, including ongoing programs and new asset development. The position works closely with R&D, regulatory affairs, and medical affairs to ensure alignment and effective planning throughout the clinical development process, while maintaining strict compliance with Ferrer QMS, ICH/GCP, and all applicable regulations and guidelines. Reports directly to the Clinical Development Director.
Responsibilities
- Provide statistical input into protocol development (e.g., trial design, sample size estimation, randomization, statistical methods for analysis) and other study essential documents such as case report form (CRF) development and edit checks for clinical trial data.
- Communicate with v...
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