Description
SUMMARY:* Perform activities related to interim analysis and data base lock e.g. data cleaning clinical data review
* Analyze and interpret study data and support preparation of reports for the FDA. Proactively provide feedback on emerging clinical and competitive trends.
Education:
* BSN, MS,MSN, Pharm.D., PhD or M.D. in related discipline and five or more years of related experience, or;
* Equivalent combination of education and experience.
Position Requirements:
* Extensive experience cleaning data
* Experience with preparing clinical study reports preferred
* Prostate Cancer experience preferred but not mandatory
* Thorough understanding of clinical trial design, in Oncology preferred and all aspects of the drug development process is essential
* Five plus years Pharmaceutical experience preferred.
* Experience in activities related to interim analysis and data base lock e.g. data cleaning / clinical data review (may include experience with safety narrative process)
Experience with EDC systems (e.g., InForm preferred)