Responsible for creating, reviewing, and maintaining statistical analysis plans, performing statistical
analysis, providing data interpretation and generating reports. These duties will be performed primarily in support of all clinical studies and regulatory submissions. Will lead effort in statistical aspects for scientific publications and presentations.
Essential Duties and Responsibilities:
- The incumbent will conduct the statistical analysis activities for all clinical trials, including but not limited to study design, statistical analysis plan, statistical programming, generate report (create tables, figures and listings, provide interpretations of the results, address limitations in study design and/or statistical method).
- The incumbent will provide statistical input in Advance Research R&D product development projects, including development of study design, formulating study endpoints, implementing appropriate statistical analysis methods, and writing Product Evaluation Reports.
- The incumbent will assist Data Management Team within Biostatistics Department when necessary review of CRF and data base structures, senior review of database locks and validation of statistical analyses macro/programs.
- The incumbent will perform statistical analysis for and regulatory documents submitted to regulatory agencies (US FDA and EU Commission), such as, but not limited to, IDEs, PMAs, 510ks or any supplemental submissions created.
- The incumbent will participate in operations meetings, address issues and represent the biostatistics unit at internal team meetings, with contract organizations and regulatory agencies, when neceassry.
- The incumbent will conduct statistical analyses and discussions for all abstracts and manuscripts created from clinical trial data and draft analyses findings and reports.
- Additional duties will include statistical consultation to manufacturing, marketing, and external investigators.
- Assumes and performs other duties as assigned.