This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 2, Band C.
In order to qualify for the Statistician position which falls under the 1530 occupational Series, you must meet the following requirements by 11:59 pm EST on 06/13/2025: Basic Qualification Requirements: A. Degree: that included 15 semester hours in statistics (or in mathematics and statistics, provided at least 6 semester hours were in statistics), and 9 additional semester hours in one or more of the following: physical or biological sciences, medicine, education, or engineering; or in the social sciences including demography, history, economics, social welfare, geography, international relations, social or cultural anthropology, health sociology, political science, public administration, psychology, etc. Credit toward meeting statistical course requirements should be given for courses in which 50 percent of the course content appears to be statistical methods, e.g., courses that included studies in research methods in psychology or economics such as tests and measurements or business cycles, or courses in methods of processing mass statistical data such as tabulating methods or electronic data processing. OR B. Combination of education and experience -- courses as shown in A. above, plus appropriate experience or additional education. The experience should have included a full range of professional statistical work such as (a) sampling, (b) collecting, computing, and analyzing statistical data, and (c) applying statistical techniques such as measurement of central tendency, dispersion, skewness, sampling error, simple and multiple correlation, analysis of variance, and tests of significance. Minimum Qualifications: Specialized experience is experience that equipped the applicant with the 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. The specialized experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience). Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and have 4 years of comparable experience (1) applying broad areas of statistical theory, including techniques to originate and develop new statistical methods (2) Provide consultation and/or analyze data from studies utilizing sophisticate analytical techniques (3) Serving as an authority on the review and conduct of various studies; Plans and executes all phases of statistical analysis and leading work/studies. OR Have a master's degree and have 3 years of comparable experience (1) applying broad areas of statistical theory, including techniques to originate and develop new statistical methods (2) Provide consultation and/or analyze data from studies utilizing sophisticate analytical techniques (3) Serving as an authority on the review and conduct of various studies; Plans and executes all phases of statistical analysis and leading work/studies. OR Have a Doctorate and/or J.D. degree and have 1 year of comparable experience (1) applying broad areas of statistical theory, including techniques to originate and develop new statistical methods (2) Provide consultation and/or analyze data from studies utilizing sophisticate analytical techniques (3) Serving as an authority on the review and conduct of various studies; Plans and executes all phases of statistical analysis and leading work/studies. OR Have a MD, DO, DDS, DPM, or DVM degree and 0 years of experience (1) applying broad areas of statistical theory, including techniques to originate and develop new statistical methods (2) Provide consultation and/or analyze data from studies utilizing sophisticate analytical techniques (3) Serving as an authority on the review and conduct of various studies; Plans and executes all phases of statistical analysis and leading work/studies. OR Have 6 years of comparable experience (1) applying broad areas of statistical theory, including techniques to originate and develop new statistical methods (2) Provide consultation and/or analyze data from studies utilizing sophisticate analytical techniques (3) Serving as an authority on the review and conduct of various studies; Plans and executes all phases of statistical analysis and leading work/studies. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Serves as the conduit within the assigned area of statistics, the incumbent plans, coordinates, and executes studies of marked difficulties and responsibilities. Assist in developing new statistical methods, Structured Query Language (SQL) queries and reports using expert knowledge of mathematical and applied statistics. Works with the team leader and the statistical reviewer to provide statistical programming and data management support. Prepares clinical trial analysis datasets; interprets the applicant's programs; assists with communication with applicants regarding specifications for regulatory information requests. Develops statistical programming solutions across projects and/or technologies to meet internal regulatory review and research needs. Serves as a technical resource on statistical methodology and its application. Writes reports and papers to support a wide range of DCEA 3-5 regulatory science activities in CDRH. Collaborates with a diverse array of project-related internal and external stakeholders, contributing to CDRH initiatives that will advance the science of medical device development and review.