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As a Social Science Analyst (Health Scienct), for the CDER, OND, Study Endpoints and Labeling Development Staff, you are the Center's leading expert on the development and vlaidation of clinical outcome assessments, which include patient-reported outcome, clinician-reported outcome, and observer-reported outcome measures as well as performance outcome measures.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-MP-1122564KC under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.
- Apply general principles of qualitative research, statistics, experimental trial design, analysis; interpretation, theories and pertinent laws, regulations, policies, and precedents to efficiently plan for and address difficult study endpoint issues to support labeling claims.
- Review and perform an in-depth evaluation of qualitative and quantitative data from research to develop clinical outcome assessments for eventual use in medical product efficacy evaluation.
- Establish review tools to ensure appropriate advice and review criteria for clinical outcome assessments for drug development submissions and drug development tool qualification submissions.
- Collaborate with other staff scientific personnel who are reviewing clinical study results to be certain that treatment benefit evaluation decisions are consistent with federal regulations.
- Assist FDA supervisory officials to evaluate and address difficult measurement issues.
- Collaborate with other team members regarding study endpoint issues and projects including guidance and policy development.
- Participate in internal and external training and communication.