View job on Handshake
Employer: US Food and Drug Administration (FDA) – Center for Devices and Radiological Health
Expires: 06/25/2021
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 Devices and Radiological Health (CDRH) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.This position(s) is located in CDRH’s Office of Clinical Evidence and Analysis (OCEA). OCEA provides:Policy and program support for clinical evidence and human subject protection and regulatory oversight of medical device clinical investigations, good laboratory practice, and good clinical practice in support of premarket review.Biostatistical and epidemiologic analyses, as well as support in the development of data infrastructure and expertise on clinical investigations and real-world evidence.We invite you to listen as a CDRH employee talks about his passion for the work he does, the Agency’s pioneering regulatory science culture and opportunities for professional growth, and why he loves working at FDA by clicking here.Major DutiesAs a Mathematical Statistician in CDRH you will:Use a variety of statistical methodologies in the review and evaluation of medical device and radiation-emitting electronic products;Determine the adequacy of information submitted and the thoroughness of statistical analyses completed regarding the scientific protocols and findings of studies submitted to the Agency by the regulated industry; andCollaborate and prepare comprehensive, concisely written reviews regarding scientific protocols and findings of studies.Basic RequirementsApplicants will be required to meet the specific qualification requirements of the following occupational series: Mathematical Statistician.Additionally, applicants must possess the required specialized experience that equipped them with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.For GS-12:Applicants must have one year (52 weeks) of specialized experience equivalent to the GS-11 grade level in the Federal service, experience includes:Performing statistical reviews to help refine protocols for medical product studies including but not limited to pivotal clinical studies, real world evidence synthesis, diagnostic device evaluation and epidemiologic studies;Commenting on the adequacy of study documentation, protocols, methodologies, data analyses, and/or interpretations of results; andUtilizing a variety of statistical methodologies for a comprehensive assessment of medical product safety and effectiveness.For GS-13:Applicants must have one year (52 weeks) of specialized experience equivalent to the GS-12 grade level in the Federal service, experience includes:Performing statistical reviews to help refine protocols for medical product studies including but not limited to pivotal clinical studies, real world evidence synthesis, diagnostic device evaluation and epidemiologic studies;Advising on the adequacy of study documentation, protocols, methodologies, data analyses, and/or interpretations of results; andUtilizing a variety of statistical methodologies for a comprehensive and thorough assessment of medical product safety and effectiveness.NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.Please see the official job vacancy announcement for: additional information; additional specialized experience, education and qualification requirements.The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.FDA is an equal opportunity employer.