Responsibilities :

- Perform senior review of TFLs and statistical analysis plans.

- Coordinate and liaise global database procedures, process, and standards.

- Perform project management activities for identified projects including resource planning, timelines, and milestone management.

- Provide input into development of case report forms (CRFs).

- Contribute to clinical study protocols and clinical study reports.

- Provide statistical input and review for complex studies.

- Serve as an independent reporting statistician on data monitoring committees.

- Accountable for the performance and results at a study level.

- Maintain expertise in state-of-the-art data manipulations and statistical analysis.

- Make recommendations or resolve technical, quality, and timeline issues.

- Consult with business development with respect to bids and timelines.

- Strategic and scientific contributions at the indication/protocol/integrated analysis level.

- Oversee large scale projects to deliver the project statistician tasks/responsibilities.

- Provide statistical input into other disciplines activities and participate in interdepartmental processes.

- Review CRF and other study specific specifications and plans.

- Create automated processes, codes, and calculations with minimum oversight.

- Perform simulations to assess various study design options and analysis approaches.

- Monitor discretionary spending in team to ensure that spending is within budget.

- Provide statistical consultation for ad hoc analysis requests including design of appropriate analysis to answer relevant questions.

- Develop trial designs that address study objectives that will support regulatory approval and market access.