Employer: Oak Ridge Institute for Science and Education
*Applications will be reviewed on a rolling-basis.A research opportunity is available with the Food and Drug Administration (FDA), as part of a multidisciplinary/multi-office collaboration between the Office of Pediatric Therapeutics within the Office of the Commissioner (OC), the Office of Translational Sciences/Office of Biostatistics, and the Office of New Drugs/Division of Bone, Reproductive, and Urological Products of the Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland.This project will involve evaluating and analyzing available data sources to determine whether gestational age (GA) at birth can be used as a primary clinical efficacy endpoint in studies of therapies to prolong pregnancy or prevent premature birth. With multidisciplinary mentorship, including statisticians and clinical review and regulatory staff, the research fellow will have the opportunity to understand how clinical trial endpoints are developed and considered in regulatory agencies and will participate in the development and execution of a statistical plan to apply existing datasets toward endpoint development. The primary aim is to better understand the ability of GA at birth to predict short-term and long-term outcomes in patients born prematurely, and to explore the utility of this endpoint for clinical trials of therapies to reduce premature birth.With a team of mentor-collaborators, the research participant will perform a focused literature review to identify and understand any previously published analyses and specify covariates, clean the identified dataset(s), and participate in the development of the statistical analysis strategy. The research opportunity also includes data management, statistical analysis, and the chance to interact with a wide variety of FDA staff, attend and present at meetings, and contribute to manuscripts and reports. The participant will be encouraged to attend FDA trainings and seminars relevant to his/her project and interests. Anticipated Appointment Start Date: as soon as a qualified candidate is identifiedQualificationsThe qualified candidate should be currently pursuing or have received a master’s or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. Completion of doctoral prequalifying exams is preferred.Preferred skills:Experience conducting research with, cleaning, and manipulating large datasetsProficiency in programming with statistical software (e.g., SAS, R, SPSS, or Stata) and ability to create reproducible codeKnowledge of applied statistical analyses, including coursework in regression, longitudinal analyses, and generalized linear modelsStrong problem-solving skills, creativity, and innovationExperience or interest in clinical trial design and/or drug developmentIf you have questions, send an email to ORISE.FDA.OC.email@example.com. Please include the reference code for this opportunity (FDA-OC-OPT-2020-0002) in your email.