Hiring Authority: This position is being filled under the streamlined hiring authority of Title 21, Section 3072 of the 21st Century Cures Act. The selected candidate will serve under a career or career-conditional appointment and will be compensated according to this authority. For more information on the 21st Century Cures Act, please refer to the 21st Century Cures Act Information.

About the FDA

The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring the safety and effectiveness of human and animal drugs, medical devices, cosmetics, foods, and more.

About CBER

The Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance public health by ensuring that biological products, such as blood, vaccines, allergenics, tissues, and cellular and gene therapies, are safe, effective, and accessible. Additionally, CBER provides public information to promote the safe and appropriate use of these products.

About ORO

The Office of Regulatory Operations (ORO) manages the review process and activities that support CBER in regulating biological products, drugs, devices, and combination products. Responsibilities include developing regulatory business processes, data standards, regulatory data analysis, program evaluation, user fee management, and managing CBER’s Information Technology investments.

Duties and Responsibilities

As a Data Scientist within the Regulatory Information Branch (RIB) under the Division of Informatics (DI) in ORO, you will play a critical role on CBER’s data team. Reporting to the RIB Branch Chief, you will be responsible for:

• Utilizing software development methodologies (e.g., Agile, Waterfall) along with necessary mathematics, coding languages (e.g., SQL), and analytics tools (e.g., JMP, R, Jupyter Notebook, Plotly, Python) to develop findings and recommendations.
• Employing Business Intelligence tools (e.g., Power BI, Tableau, Power Apps) for dashboard and report development.
• Applying statistical methodologies to extract insights from both structured and unstructured data.
• Conducting data mining, analysis, modeling, and algorithm development.
• Translating analytical results into actionable recommendations, facilitating data-driven decision-making for CBER leadership.
• Troubleshooting technical issues by analyzing and modifying code and communicating data architecture to technical and non-technical audiences.
• Delivering reports and information to support CBER leadership and product office teams.
• Collaborating with internal stakeholders to understand business processes, gather requirements, and develop analytical methodologies.
• Recommending technology implementations and leveraging data collection processes to enhance data access and usability.
• Working with subject matter experts to identify relevant information sources and make strategic recommendations regarding data collection and retention.
• Providing strategic guidance and hands-on support in data transformation and management.
• Adapting and managing changes to products in response to evolving user needs.
• Collaborating with design staff to improve data quality, performance, and overall user experience.

How to Apply

To apply, please submit your electronic resume or curriculum vitae (clearly detailing your years of experience, including months and years, along with a description of duties), SF-50 (if applicable), latest PMAP (if applicable), unofficial transcripts, and a letter of interest. Please include “CURES CBER/ORO/DI/RIB Data Scientist” in the subject line and send your application to: [email protected]. Applications will be accepted until 10/29/24.

Contact Information

For questions regarding this Title 21 (Cures) position, please reach out to [email protected].

The Department of Health and Human Services is an equal opportunity employer committed to maintaining a smoke-free environment. The FDA is an equal opportunity employer.