FDA Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Summary: The Oak Ridge Institute for Science and Education is offering a research opportunity with the U.S. Food and Drug Administration (FDA) focused on assessing rare safety signals in psychiatric clinical trials. The role involves investigating mortality patterns and suicidal ideation in patients receiving psychiatric medications, while contributing to peer-reviewed research and presentations. Responsibilities: - You will investigate mortality patterns in elderly patients receiving antipsychotics, analyzing clinical trial data and real-world evidence to quantify the mortality risk estimate and to characterize temporal patterns, dose-dependent relationships, and potential underlying mechanisms - You will investigate the occurrence of suicidal ideation and behavior in adults and pediatric patients receiving an antidepressant. Analyses will include a comparison of event ascertainment based on unsolicited adverse event reporting and use of a prospective clinical outcome measure between adults and pediatrics - For both research activities, you will research innovative approaches for detecting rare adverse events and consider the impact of baseline patient characteristics, psychiatric comorbidities, and changes in the underlying condition. Through these efforts, you will also have the opportunity to gain experience in contributing to peer-reviewed manuscript preparation, presentation of research findings at internal and external scientific meetings and communicating complex research initiatives Required Qualifications: - Currently pursuing or have received a master's or doctoral degree in one of the relevant fields - Citizenship: LPR or U.S. Citizen - Degree: Master's Degree or Doctoral Degree - Discipline(s): Life Health and Medical Sciences (Pharmacy, Public Health) or Social and Behavioral Sciences - Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA - Proof of health insurance is required for participation in this program - FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date Required Skills: Master's Degree, Doctoral Degree Important Skills: Life Health Sciences, Medical Sciences, Social Sciences Nice-to-Have Skills: Research Skills, Statistical Analysis, Communication Skills Benefits: Proof of health insurance is required for participation in this program., Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.