The appointment for a clinical analyst is a full-time employee (FTE) at FDA in Silver Spring, Maryland. The incumbent is located in OND (Office of New Drugs), CDER (Center for Drug Evaluation and Research), FDA. The role of a clinical analyst is to support OND’s Integrated Review for New Drug Marketing Applications program by conducting comprehensive safety data quality assessments and safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers.
- Develop and execute the safety data review plan (SDRP) in alignment with clinical reviewers and with input from statistical reviewers.
- Provide written reports regarding the assessment of safety data sufficiency, integrity, and quality.
- Perform safety data analyses and provide written reports containing standardized safety tables and figures.
- Verify safety data submitted by the applicant in the clinical study report, integrated summary of safety, and proposed drug label.
- Conduct in-depth safety analyses for specific safety signals and issues as requested by clinical review teams.
- Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses.
- Collaborate with CDER OND staff to optimize team processes and deliverables.
- Be U.S. citizens.
- Have a Ph.D. (in pharmaceutical sciences, pharmacology, data science, informatics, public health, or epidemiology related fields) or Pharm.D. degree.
- Possess strong R programming skills of data analysis and a deep understanding of clinical data structure, clinical trial design, and safety data analytical methods.
- Have excellent communication skills.
Vacancy Type: Full Time
Job Location: Philadelphia, PA, US
Application Deadline: N/A