What do Clinical Analysts do at CDER?
The duties of a Clinical Analyst at CDER differ by office. Opportunities may include:
- Serving as the clinical expert on a multi-disciplinary scientific team in the review and evaluation of scientific data to assess investigational new drug or biologics applications (INDs) and new drug applications or new biologic licensing applications (NDAs/BLAs).
- Providing advice to pharmaceutical sponsors and investigators regarding development programs throughout the drug development process.
- For INDs, evaluating development plans and study protocols to determine if they are safe and if the design is likely to generate evidence of effectiveness.
- For NDAs and BLAs, reviewing and evaluating reports of clinical trials to determine if the data are adequate, well controlled, and sufficient to support the efficacy and safety of the drug under investigation.
- Reviewing submissions in support of revisions to labeling of approved NDAs or BLAs with respect to new safety findings, including appropriate warnings and precautions, claims about new efficacy findings, and adequate instructions for dosing and administration.
- Reviewing post-marketing safety reports and periodic safety submissions to determine if there are potential issues that require further evaluation.
- Keeping abreast of the progress in clinical and related sciences by reviewing the scientific literature, attending conferences, and participating in staff seminars where cases and special topics are discussed.
Related positions include:
- Computer Scientist
- Data Scientist
- General Health Scientist
- Mathematical Statistician
- Operations Research Analyst
How can I find a Clinical Analyst position at CDER?
Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.
- Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 0601 - General Health Science.
- Visit We Are Hiring | FDA to find a current listing of opportunities utilizing the FDA 21st Century Cures Act Hiring Authority.
Where can I learn more about careers at the FDA?
For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.