STAFF FELLOW – MEDICAL INFORMATICS
(Computer Scientist), RG-1550
Office of Biostatistics and Epidemiology (OBE)
Center for Biologics Evaluation and Research (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
Department of health and human services (HHS)
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Epidemiology (OBE), Immediate Office of the Director (IOD) is recruiting to fill a Staff Fellow position to work collaboratively in the CBER Sentinel Program.
The CBER Sentinel Program is part of the FDA’s Real-World Evidence Program (RWE). FDA’s working definition of Real-World Evidence, is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data (RWD). To improve and modernize the ability to assess the safety and effectiveness of regulated biologic products licensed under section 351 of the Public Health Service Act, the CBER Sentinel Program works on the following:
- Developing and implementing data standards and data quality assessment in the CBER Sentinel Program for fit for purpose to address safety and effectiveness of biologic products.
- Implementing signal detection capacity in the CBER Sentinel Program to streamline the identification of potential safety risks related to biologic products.
This position will be filled through the Service Fellowship program. The appointment is for up to four years with opportunities for renewal. Applications will be accepted from U.S. citizens or Lawful Permanent Residents (green card holders) only. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.
The selected candidate will collaboratively work with the CBER Sentinel Program for the following major duties:
- Provide expertise in data standards and controlled clinical terminologies and ontologies (UMLS, SNOMED, ICD, LOINC, etc.) used in administrative claims and EHR data and integrating with natural language processing (NLP) applications.
- Develop and implement data standards and data quality assessment programs to assure RWD housed within the CBER Sentinel infrastructure is fit for purpose.
- Establish targets (desired state of specific data quality attributes) and thresholds (minimum level of quality acceptable) to assess and ensure data fitness for regulatory purposes.
- Identify and establish approaches for data traceability across the network of disparate databases in CBER Sentinel Program for regulatory decision-making.
- Apply semantic web technologies to transform high-dimensional information in the unstructured provider notes in EHRs into signal detection of adverse events related to biologics.
- Synthesize the unstructured free text into standardized text string devoid of protected health information for automated searches of biologics exposures and adverse events.
- Developing information retrieval and extraction techniques using NLP and machine learning in EHRs for secondary use in epidemiologic studies, e.g., identify patterns associated with clinical characteristics to improve cohort identification, patient selection for study inclusion, capture and adjustment of exposures, outcomes, covariates, and confounders.
Location/Region: Waldorf, MD (20601)