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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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

 

Introduction

The Food and Drug Administration (FDA or Agency) 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 Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

 

The Office of Regulatory Operations (ORO) is responsible for managing the review process and associated activities used to support CBER in facilitating the regulation and review of biological products, drugs, devices, and combination products. These responsibilities include development and governance of regulatory business processes; data standards; regulatory data analysis; program evaluation; resource utilization; user fee management; electronic submission management; and special initiatives. ORO manages CBER’s Information Technology investments throughout their lifecycle to support and ensure CBER’s review, scientific, and administrative needs are met.

 

Duties/Responsibilities

The incumbent serves as the Data Scientist for the Regulatory Information Branch (RIB) within the Division of Informatics (DI) under the Office of Regulatory Operations (ORO). This position reports to the RIB Branch Chief. The Data Scientist (BI) is a critical part of the Center for Biologics Evaluation and Research (CBER) data team; responsible for data analytics development, data advisory services, and support for data utilization in CBER. Personnel will collaborate with business users, Data Architect(s), Information Technology Team(s) as well as other CBER stakeholders and data components in the delivery of quality data analytics, reporting, and visualization/dashboard tools that will enable data-driven decision making across the Center.

 

Specifically, the Data Scientist will:

 

  • Utilize software development methodologies (e.g. Agile, Waterfall), the necessary mathematics, coding languages (e.g., SQL), and analytics tools (e.g., JMP, R, Jupyter Notebook, Plotly, Python) to develop findings, conclusions, and recommendations.
  • Utilize Business Intelligence tools (e.g., Power BI, Tableau, Power Apps, Business Objects) for dashboard and report development.
  • Use statistical methodologies, processes, and algorithms to extract descriptive, inferential, predictive, and prescriptive insights from structured and unstructured data.
  • Conduct data mining, analysis, modeling, development of algorithms and computer program design activities.
  • Translate results of analysis into clear, actionable recommendations, resulting in clear communications that equip CBER decision makers to make data driven decisions, supported, and informed by appropriate products.
  • Troubleshoot and resolve technical issues by performing analyses, writing, or modifying code, and explaining data architecture and design to both technical and non-technical audiences.
  • Deliver reports and relevant information to support the needs of CBER leadership and product office teams.
  • Interact with internal customers and colleagues to understand business processes, gather requirements, develop analysis methodologies, and coordinate ongoing iterative development of data products.
  • Recommend the implementation of existing technologies and techniques related to data science, identifies available and relevant data, including internal and external data sources, leverages new data collection processes, and preforms all phases of the systems development life cycle required for the design, development, and implementation of new tools enabling data access.
  • Collaborate with other subject matter experts to select relevant sources of information, as needed, to preform job duties and makes strategic recommendations on data collection, integration, and retention requirements incorporating business requirements and knowledge of best practices.
  • Provide strategic and technical guidance and hands-on support in the transfer and transformation of any required data.
  • Identify, adapt, and manage changes to products or programs in response to evolving user needs.
  • Recommend usage and access control policies and systems in collaboration with system design staff and stakeholders to continually improve processes impacting data quality, performance enhancements, and overall user experience.

 

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), latest PMAP (if applicable), unofficial transcripts and letter of interest with “CURES CBER/ORO/DI/RIB Data Scientist” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through February 1, 2024.

 

Announcement Contact

For questions regarding this Title 21 (Cures) position, please contact CBERHumanCapital@fda.hhs.gov.

 

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.

 

FDA is an equal opportunity employer.