The associate will review and organize essential study documentation to ensure compliance with FDA regulations and GCP guidelines. They will also assist in audit preparation, IRB submissions, and the maintenance of company standard operating procedures.
The Statistician/SAS Programmer will conduct statistical analysis by generating tables, listings, and figures while validating data for FDA submissions. They are also responsible for developing statistical programs and assisting with proprietary macro development.
Conduct remote interviews with study participants via video conference and obtain informed consent. Enter participant responses into data collection systems while ensuring data integrity.
