FDA NLP Consumer Data Review Fellowship
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IT/Tech
Job Description & How to Apply Below
A research opportunity is available immediately with the Food and Drug Administration (FDA), Silver Spring, Maryland.
Description- Applications will be reviewed on a rolling-basis.
Consumer studies, essential to OTC drug approval, usually enroll several hundred participants, with each participant answering more than a dozen study questions, resulting in large volumes of verbatim data. As an Oak Ridge Institute for Science and Education (ORISE) participant, you will join and learn from a community of scientists and researchers engaged in an effort to use natural language processing (NLP) to automate FDA’s review of these qualitative responses, potentially providing both more accurate and efficient review of consumer data.
LearningObjectives
- Describe the role of consumer studies in the FDA's OTC drug approval process and explain why large volumes of verbatim data present challenges for regulatory review.
- Identify the structure and content of typical consumer study datasets, including the types of questions asked and the nature of participant responses.
- Define core NLP concepts relevant to text analysis, such as tokenization, text classification, and named entity recognition.
- Compare traditional rule-based NLP approaches with modern machine learning-based approaches and articulate when each may be appropriate in a regulatory context.
- Apply NLP tools and frameworks to process, analyze, and classify qualitative consumer study responses.
- Evaluate NLP model performance using appropriate metrics and interpret results in the context of regulatory review requirements.
- Identify potential sources of bias and error in NLP-assisted review and articulate strategies for mitigating them.
The mentor for this opportunity is Yong Ma (yong.ma.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start DateDecember 2026. Start date is flexible and will depend on a variety of factors.
Appointment LengthThe appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of ParticipationThe appointment is full time.
Participant StipendThe participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship RequirementsThis opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. 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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
QualificationsThe qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields.
- Citizenship: LPR or U.S. Citizen
- Degree:
Master's Degree or Doctoral Degree. - Discipline(s):
- Computer, Information, and Data Sciences (
- Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning)
- Computer Architecture and Grids
- Computer Science
- Languages and Systems - Computer Science
- Theoretical Foundations - Computer Science (general)
- Computer Systems Analysis
- Computer Systems Design (including Signal Processing)
- Data Science
- Databases, Information Retrieval, and Web Search
- Graphics and Visualization
- Human Computer Interaction
- Information Science and Technology
- Information Security and Assurance
- Networks and Communications
- Operating Systems and Middleware
- Scientific Computing and Informatics
- Software Engineering
- Mathematics and Statistics (11 )
- Social and Behavioral Sciences (1 )
- Affirmation
- I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
Ashley
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