Responsible for providing statistical support in the execution, analysis and reporting of clinical trials for Company products. The position ensures the statistical integrity of the clinical data analyzed. Assists with identifying and supporting new efficiencies and technologies for clinical data collection, analysis, and reporting. In addition, this person will also assist with the preparation of responses to regulatory agency questions regarding statistical aspects of clinical trials and other investigative study designs and analyses.
Essential Duties and Responsibilities:
- Assist with generation of appropriate procedures and policies to conduct statistical analysis of clinical trial data.
- Assist in the preparation of the statistical methodology section of the synopsis and the statistical procedures section of the protocol, including calculating the required sample size and power and ensures the accurate generation of the randomization as appropriate.
- Assist with implementing standardized approaches to data analysis as appropriate.
- Assist with preparing and maintaining the Statistical Analysis Plan (SAP) which includes the description of the planned data analyses, statistical methodology, derivation of analysis variables, and formatting of all tables/listings/figures. Ensure consistency in statistical methodology, programming standards, and data specifications with all studies.
- Collaborate with various parties including data management, clinical and regulatory affairs to ensure successful implementation of the project plan.
- Program and produce tables, listings and graphs for the clinical documents (study reports, publications, regulatory submissions, etc.) in accordance with the methodology detailed in the
- SAP and the timelines specified in the project plan.
- Reviews the accuracy of numerical and quantitative statements in the clinical document as well as interpretation of statistical results.
- Participates in departmental committees/teams for development and improvement of work process, procedures, and standards.
- Other duties as assigned
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work.