This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates the over the counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.
The Office of Quality Surveillance (OQS) is OPQ's focal point to assure that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.
Duties/Responsibilities
As a Data Scientist , the incumbent serves as a specialist in the application of data science, operations research, computer science, mathematics, and statistics, to design data modeling processes, uncover hidden patterns in the data, and create algorithms and predictive models to extract insights that improve the assessment of the state of pharmaceutical quality.
Applies knowledge of statistical modeling, descriptive multivariable statistics, feature engineering, machine learning, predictive modeling, computer science, and data mining to gather, analyze, model, interpret quantitative information, anomalies, patterns, and correlations among data sets that are managed by OQS.
Verifies and analyzes model performance and accuracy.
Applies modern approaches to identify emerging trends and clusters in post-market defect reports.
Designs drug sampling and testing plans that target low-quality and high-risk drug products.
Supervisory Responsibilities: N/A
How to Apply
All qualified candidates will submit their cover letter, resume, and transcripts to ********
no later than May 17, 2024. The application period will either close on May 17, 2024, or after the Agency receive 100 resumes (applications). Once that number has been reached, the vacancy announcement will close.
A resume, not a CV, must be received. You can access the USA Jobs Resume Builder to assist with building your resume.
If you have foreign transcripts, please submit the foreign transcript course-by-course evaluation from an accredited company ( NACES or AICE ). Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with "do not share".
Please reference Job Reference ID: OQS Data Scientist in the subject line.
How You Will Be Evaluated
Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.
Announcement Contact
For questions regarding this Cures position, please contact ******** .
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.
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