Associate Director Biostatistics
- North Carolina
- Pharma & Biotech
- Manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects.
- Coach, mentor, develop, provide technical review, advice and expertise to direct subordinate Biostatisticians and Statistical Programmers as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.
- Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.
- Provide statistical oversight on projects
- Provide statistical input in protocol design and development.
- Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.
- Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
- Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients.
- Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentation.
- Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirement/expectation (e.g. CDISC).
Sthree US is acting as an Employment Agency in relation to this vacancy.