FDA | Hiring | Data Scientist | Silver Spring, MD | BigDataKB.com | 2022-09-29

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Job Location: Silver Spring, MD

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 Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over- the-counter drugs (OTC). CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.

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

Conditions of Employment

  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Direct Deposit: You will be required to have 2all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
  • Males born after December 31, 1959, must be registered with the Selective Service.
  • One-year probationary period may be required.
  • Financial Disclosure may be required.
  • Ethics Clearance may be required.
  • Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

  1. Scientific, Technical, and Professional Fields
  2. Qualified and Outstanding Candidates
  3. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
  4. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement:

Data Scientist (Miscellaneous Administration and Program Series), AD-0301 Series

  • There are no Individual Occupational Requirements for this series.

Desired Education:

Our ideal candidate will possess:

Education training or experience in such fields of statistics, or similar computationally intensive field providing the skills necessary to serve as a data scientist.

Desired Professional Experience:

Our ideal candidate will possess:

  • Ability to apply the principles, concepts, tools, and methodologies related to data science. Emphasis on forecasting and predictive analytical techniques, including machine learning techniques.
  • Demonstrated analytical ability for independent work on complex, multipart tasks, judgement, and discretion in executing Food & Drug Law activities.
  • Ability to select, interpret, and apply relevant guidelines to determine appropriate course of action.
  • Ability to work independently and collaboratively across organizational boundaries.
  • Skill in oral and written communication sufficient to present technical information or recommendations, to explain the requirements to conduct an analytical study, and disseminate information to senior management.
  • Project management experience with skills that include complex multifaceted projects.

How to Apply

All qualified candidates should submit their resume with cover letter and unofficial transcripts (if you have foreign transcripts, please submit a course-by-course foreign evaluation from an accredited company (NACES or AICE) by October 12, 2022 to OPQOQSRecruitment@fda.hhs.gov. 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 ID: OQS – Data Scientist

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 Dominique.Mitchell@fda.hhs.gov.

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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