FDA Pediatric Cardiovascular Drug Database Engineering Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Division of Cardiorenal Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Pediatric drug development submissions have increased after enactment of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) with no comprehensive tracking system. Fragmented efforts at tracking have led to inconsistencies in data entry and information capture, compounded by incompatibilities among different IT systems. Utilization of knowledge management for creation of a modern, comprehensive, searchable pediatric database is needed to reliably track outcomes of these programs. This will optimize compliance with PREA requirements and provide a resource to facilitate consistency in FDA advice and actions. The goal of this project is to leverage FDA IT infrastructure and assets to create an expandable pediatric database that will provide a more comprehensive tracking tool and improve efficiency.
Under the guidance of a mentor, the participant will receive instruction about pediatric drug regulation and limitations of knowledge management tools used to track pediatric drug development programs. The participant will also have the opportunity to learn about FDA's IT submissions software, for example the Document Archiving, Reporting and Regulatory Tracking System (DARRTS), from which data will be extracted and receive mentoring related to the process of building a customized, automated, searchable, comprehensive and upgradeable data interface. In addition, the participant will learn development of methods to support integration of the database with the current IT infrastructure.
Qualifications
The qualified candidate should be currently pursuing or have received a bachelor's or master's degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Preferred skills:
- Familiarity with searching within files and databases (manually and using SQL)
- Data management and automation processes, including data standardization, transformation, validation, loading and analyses
- Familiarity with database and information management programs (Microsoft Access, SQL Server, SharePoint, etc)
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0506) in your email.