FDA Evaluation of Reproductive Therapies Fellowship

FDA Evaluation of Reproductive Therapies Fellowship

Organization: U.S. Food and Drug Administration (FDA)
Reference Code: FDA-CDER-2020-0487

A complete application consists of:

An application

Transcripts –

A current resume/CV, including academic history, employment history, relevant experiences, and publication list

One educational or professional recommendation. 

Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

Application Deadline
6/30/2020 3:00:00 PM Eastern Time Zone

Description

Applications will be reviewed on a rolling-basis.

A research opportunity is currently available in the Office of Translational Sciences/Office of Biostatistics at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The Office of Biostatistics is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle. To support CDER’s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.

This project seeks to determine whether there are more distal endpoints than clinical pregnancy that could reliably predict live births during Assisted Reproductive Technology (ART) procedures in women. The project will determine if one or more parameters could be used as endpoints in future clinical trials for drug, biologic and biosimilar products that are seeking an indication of treatment of women undergoing ART therapy.

Under the direction and guidance of a mentor, the participant will be involved in the following opportunities:

Learning how to access the Center for Disease Control (CDC) database
Evaluating the database structure
Writing code for consolidating the relevant data for the project objective
Creating analysis data files
Writing statistical analysis plans to handle potential statistical issues related to such health related databases

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, MD, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
Non-employee nature of the ORISE appointment;
Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
The fact that research materials and laboratory notebooks are the property of the FDA;
ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

Qualifications

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in biostatistics, statistics, applied mathematics, or related fields with a strong emphasis on programming, data science, and modeling. Degree must have been received within five years of the appointment start date.

Preferred skills:

Familiarity with use of large survey data stored in relational databases
Experience in written and oral communication with clinicians, epidemiologists, and biostatisticians
Experience with R and SAS programming
Basic knowledge of clinical research and human reproduction
Familiarity with data management, longitudinal survey data, and statistical approaches to model building, calibration and validation to evaluate and develop biomarkers or algorithms for use as surrogate endpoints
Familiarity with joint modeling techniques using large longitudinal databases, including modeling of longitudinal intermediate outcomes
Eligibility Requirements

Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.

Discipline(s):
Life Health and Medical Sciences
Mathematics and Statistics
Social and Behavioral Sciences

APPLY HERE