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Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Regulatory Operations (ORO)

Division of Informatics (DI)

Regulatory Information Branch (RIB)

Application Period: January 18, 2024 – February 1, 2024

Area of Consideration: The Public

United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents 

are not eligible for consideration.

Position: Data Scientist Series: 0301

Location(s): Remote Eligible position

Work Schedule: Full Time

Title 21 Band: C

Salary: Starting at $112,015 is set commensurate with 

education and experience.

Telework Eligible: Yes – as determined by agency policy

Full Performance Band Level: C

Travel Requirements: 25% or less Bargaining Unit: 3591

Note: Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will 

require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement 

does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, 

recruitment, or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual 

leave for prior non-federal work experience or prior uniformed military service, etc. 

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 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 
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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.

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 all 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 supervisory probationary period may be required. 
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• 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 Title 21 (Cures) position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Title 21 appointments. The FDA OTS will use the basic requirements 

defined in the below Education/Graduate Training Requirements as a baseline for comparing experience 

levels and other candidate attributes for relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance 

rating, or both.

In order 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/Experience Requirements:

Education: A bachelor’s degree or higher in mathematics, statistics, computer science, informatics, data science, engineering, 

operations research, bioinformatics, economics, public health, computational biology, physics, or related scientific or technical

field. The degree must be from an accredited program or institution.

OR

Experience: Comparable work in or demonstrated understanding in data science or a related field (through portfolios, 

certifications, etc.).

Position’s Desired Skills, Experience, or Education:

➢ Education: A bachelor’s degree in computer science, Information Technology, or related field.

➢ Proven experience as a Business Intelligence (BI) Developer or similar role.

➢ Proficiency in BI tools and technologies (i.e. Power BI, Tableau, Business Objects (BO)).

➢ Strong SQL and scripting skills.

➢ Knowledge of Oracle and experience using TOAD to navigate databases.

➢ Strong knowledge of report development, data visualization and dashboarding concepts.

➢ Strong analytical and problem-solving skills.

➢ Excellent communication and teamwork skills.

➢ Attention to detail with a commitment to data accuracy and quality.

Technical Skills:

➢ Ability to adapt to changing working conditions and work assignments, motivated to learn and adapt new software 

tools, ideas, and concepts, and to work independently or as part of the team to work on multiple tasks.

➢ Capable of clear and sound reasoning, with a demonstrated ability to use sound judgement in practical matters.

➢ Ability to multi-task and provide deliverables within fixed timelines, as well as the ability to work well in a dynamic 

environment and meet overall objectives.

➢ Working knowledge of the principals of Systems/Software Development Life Cycle (SDLC).

➢ Demonstrates experience with fundamentals, principals, and processes related to change control for information 

systems.
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➢ Working knowledge of basic analytics/statistical principles, and the ability to synthesize complex information into an 

easy-to-understand manner.

➢ Knowledge of business workflow and associated terminologies, and the ability to document them with industry 

standard tools such as Visio or PowerPoint.

➢ Creating and maintaining consistent reference data and integrate data from various homogenous and 

heterogeneous source system, including the creation and maintenance of data dictionaries, entity relationship 

diagrams, and business glossaries.

➢ Experience analyzing and testing enterprise data for quality and consistency and working with stakeholders to 

reconcile data issues across data repositories.

➢ Knowledge of project and system development methodologies (e.g., Agile, Waterfall) and the demonstrated ability 

to apply and adopt methodologies to align with project needs and drivers.

➢ Ability to maintain detailed project plans that include milestones, tasks, and target/actual dates of completion.

➢ Ability to create technical and business documentation including white papers, knowledgebase articles, system 

diagrams, workflow diagrams, and presentations.

➢ Experience with workflow analysis and process redesign to improve efficiency and performance.

➢ Demonstrates ability to develop metrics and reporting frameworks to measure efficiency and effectiveness, facilitate 

appropriate resource allocation, and increase the maturity of programs.

Communication Skills:

➢ Possess outstanding communication (written and verbal), listening and interpersonal skills, and able to quicky 

establish credibility and rapport with a broad set of stakeholders.

➢ Proven track record of collaboration and relationship building across diverse teams.

➢ Ability to prepare and give presentations, and to communicate (written and verbal) complex technical content to 

technical and non-technical stakeholders.

➢ Ability to work with customers to conduct detailed requirements gathering and analyze information to translate 

customer objectives into a detailed technical implementation plan.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational 

requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and 

Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA 

employee, you are not exempt from transcript requirements.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification 

requirements, you must show that the education credentials have been evaluated by a private organization that specializes in 

interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited 

U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more 

information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: 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. 

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If 

you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on 

this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web 

page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. 

Equal Employment Opportunity 

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including 

pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic 

information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit 

factor. Equal Employment Opportunity (EEO) for federal employees & job applicants
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Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants 

requiring reasonable accommodation for any part of the application process should follow the instructions in the job 

opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. 

Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation 

is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to 

apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies 

must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal 

opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or 

to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, 

such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the 

application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability 

employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). 

E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

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.