The position will support clinical trials by developing statistical analysis plans for clinical trials and author the final statistical report. This position will be point of contact for FDA questions pertaining to analysis. The position will also assist in any supporting analysis such as precision and reproducibility studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity study carried out by development or the clinical trial group.
- Develop Statistical Analysis Plans and Justify Sample Sizes for Alpha, Beta, Clinical Trials, and CE/IVD trials.
- Write final statistical analysis report for final submission to FDA.
- Maintain all statistical software licenses and ensure all statistical licenses are up to date. This includes SAS, SASjmp, and Minitab site licenses.
- Stay current on product development issues and stages of clinical trials by attending research review and development team meetings.
- Support R&D with statistical support and advise as needed.