The position is responsible for statistical methodology and statistical analysis plans for clinical projects, and acts as the project statistician on complex trials and across multiple studies.
Your responsibilities will be the following:
* Act as the core project team lead to coordinate and manage all statistical project activities
* Providing statistical liaison with the client and input for protocol and CRF development.
* Prepare statistical analysis plan
* Perform validation and statistical quality checks on computer-generated output to verify accuracy.
* Prepare or review key portions of the integrated clinical/statistical report, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy and safety results.
* Attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
* Following departmental SOPs, OGs and relevant regulatory guidelines (e.g. ICH).
Supervise, coach, and mentor staff
Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges