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Associate Director Biostatistics

Location: North Carolina Salary: competitive
Sector: Pharma & Biotech Type: Permanent
  1. 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.
  2. 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.
  3. 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.
  4. Provide statistical oversight on projects
  5. Provide statistical input in protocol design and development.
  6. 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.
  7. Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
  8. 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.
  9. 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.
  10. 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).

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