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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 Biostatistics and Pharmacovigilance (OBPV)

Division of Biostatistics (DB)

Therapeutics Evaluation Branch 1 (TEB1)

Application Period: January 29, 2024 – February 9, 2024

Area of Consideration: HHS-wide

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: Mathematical Statistician Series: 1529

Location: Remote

Telework Eligible: Yes – as determined by agency policy.

Work Schedule: Full Time

Salary: Starting at $139,395 

Travel Requirements: 25% or less

Bargaining Unit: 3591 

Cures Band: D Full Performance Band Level: D

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 mission of the Office of Biostatistics and Pharmacovigilance (OBPV) involves evaluating the safety and efficacy of the spectrum of 

CBER products throughout their entire lifecycle, from preclinical to post-marketing. OBPV scientific disciplines include experts in 

epidemiology, statistics, medicine, risk analysis, public health, genomics, and other scientific areas.

Duties/Responsibilities

The incumbent serves as a Mathematical Statistician for the Therapeutics Evaluation Branch 1 (TEB1) within the Division of Biostatistics 

(DB) as well as a specialist in statistical methodology and its applications and collaborate with other Divisions in CBER regarding the 

evaluation of regulated studies and the conduct of primary research activities. Specifically, the incumbent serves as a program specialist 

and consultant advisor for statistical problems and provides collaborative contributions to the regulatory and scientific programs of the 

Center.
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Specifically, the Mathematical Statistician will:

➢ Serves as a nationally authoritative regulatory review scientist, providing technical leadership and guidance for regulatory activities 

in the areas of vaccines, blood products and cellular, tissue and gene therapies. 

➢ Performs Reviews of IND and IDE submissions, 510(k) applications and BLA, NDA and PMA submissions and supplements, especially 

those related to vaccines, cancer immunotherapies, leukemia, cell therapies, and rare diseases including inherited blood disorders.

➢ Provides recommendations to CBER review organizations, review scientists, and the regulated industry. Represents the Center at 

local, state, and national meetings on statistical matters concerning OVRR, OBRR, and OTP-related products.

➢ Determines the adequacy of statistical data and analyses submitted by an applicant regarding the safety and effectiveness of a 

regulated vaccine or blood or advanced therapy product.

➢ Participate in meetings between the Center and regulated industry and advises on adequacy of statistical aspects of study plans and 

product development. 

➢ Participate in activities of professional societies regarding the design, conduct, and analysis of regulated clinical trials, and other 

related statistical methodology. As necessary, the incumbent will attend special conferences, hearings, etc. with industry as well as 

the professional community, and may serve on committees, organize sessions, give oral or poster presentations, etc.

➢ Confer with other federal government agencies on joint projects and programs, mutual problems, and areas of interest, etc. 

➢ Perform other duties assigned. 

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.

• 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.

• 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

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the

below Education 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.

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 Requirements:

A bachelor’s degree or higher in mathematics, biostatistics, statistics, or in a related math field. Degrees in math education are not 

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

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, 
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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.

Desired Professional Experience, Skills, or Education

• Our ideal candidate will possess a Ph.D. or equivalent terminal degree in biostatistics, statistics, or a closely related field.

• Candidate would ideally have relevant data analysis experience in clinical trials and/or other clinical studies. 

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

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 caseby-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). No assumptions will be made regarding your 

experience. Along with your electronic resume or curriculum vitae, please submit a copy of unofficial transcript(s), SF50 (if applicable), 

latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OBPV/DB/TEB1 Mathematical Statistician” in the subject 

line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through February 9, 2024. 

Announcement Contact

For questions regarding this 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.