The incumbent serves as a statistician and data analyst on the Data Analytics and Evaluation Staff (DAES) within the Office of the Associate Commissioner for Regulatory Affairs (OACRA). DAES is the primary group within ORA responsible for developing performance metrics and conducting crosscutting assessments on a variety of operational, financial, enforcement and compliance activities. Our analysis and reports are used by both internal and external stakeholders to assess ORA’s progress and proficiency in accomplishing our regulatory objectives.
Functional duties and responsibilities: Serve as a technical expert with respect to all phases of statistical planning and evaluation analyses relating to topics under consideration. Develops and delivers analytical dashboards to display critical data by meeting with users and stakeholders to gather requirements, map process flows and understand project or program objectives. Utilizes existing technological tools to extract, transform, load (ETL) data to make large data sets usable for further analysis and dashboard creation. Develops new methods and systems to assist, automate and improve regular and accurate data collection. Assist in the development of metrics and goals to measure on-going activities and ad-hoc initiatives. Manage, manipulate, and analyze large data sets, prepare assessments, reviews and reports to senior leadership, Congress, and the media. Interprets technical analysis into language that can be widely consumable by non-technical audiences.
Serves as an expert on data management and governance principles and best practices. Advise strategic IT and data system upgrades to ensure that changes enhance reporting, compliance, and oversight ability. Advises ORA staff on issues related to scientific validity, merit of research protocol and analytical approaches. Recommends study design, execution, and data collection to ensure standard research and analysis protocols are maintained.
Deploys a variety of mathematical and statistical methods to create novel approaches, including optimization methods, forecasting and estimation, economic and decision analysis, probability and statistics, and operations research. Leverage programming languages and code when and where necessary to extract information from unstructured data to build structured data sets for further analysis. Employs automation tools and techniques to improve data reliability, decreasing burden of collection and streamlining efficiency.
Mentors and provides instructions to ORA staff in various research disciplines, study design and mathematical approaches. Prepares papers, reports, or other documents for presentation to professional groups, senior FDA Management, Program Directors, Field Committees, or for publications in professional journals. When appropriate, the incumbent will represent this discipline to the professional and academic communities, and to the regulated industry. Serve as a liaison with other organizations within the agency, the Department, and other federal, state, and local agencies.
Analyze assessments of operational, policy and resource issues or concerns. Leverage theoretical concepts and practical applications to inform the approach, analysis, and conclusions. Explain critical and significant statistical concepts, establish methodologies, procedures, guidelines, and policies.
Supervisory responsibilities: This is not a supervisory role.
Education Requirement: Candidate must qualify for the following series: Statistics Series 1530
Position’s Desired Skills, Experience, or Education:
Graduate or higher-level degree.
Demonstrated experience in:
data visualizations tools: Tableau, PowerBI, GIS
database and reporting packages: BusinessObjects, SQL
statistical software/programs: SAS, SPSS, Excel
automation tools: MS PowerApps, Python
programming: XML, JavaScript, ETL
In-depth knowledge of analysis tools and techniques to analyze and evaluate the efficiency and effectiveness of agency programs; select appropriate qualitative and quantitative techniques for a specific situation; and develop and apply new approaches for conducting complex, comprehensive studies which deal with major issues affecting program
Expert knowledge of information technology principles sufficient to lead projects to automate processes and procedures and to disseminate programmatic
Mastery of and skill in applying advanced, analytical, mathematical, or statistical theories, principles, concepts, methods, and techniques related to statistical analysis; parametric and non-parametric analysis; computer modeling; decision theory; mathematical programming; regression analysis; business intelligence; data analytics; and economic analysis in order to design and develop the most appropriate techniques that enable the incumbent to solve problems, enhance performance, and/or increase efficiency and effectiveness
Highly skilled to develop, implement, evaluate, and improve processes and procedures concerning ORA special studies and analyses.
Expert knowledge of management and administrative goals, objectives, systems, regulations, guidelines, and processes of an HHS organization or major organizational
Comprehensive professional knowledge in conducting research to recommend improvements in study design and data collection and contributes to the plan and preparation of research protocols.
Skill in verbal communication to make clear, convincing presentation; influence managers and other officials to adopt and implement recommendations; to gain cooperation and input from others on broad studies and projects; to lead presentations to high-ranking officials; to represent the organization at meetings, conferences, and on workgroups, and to provide technical assistance to Federal and non-Federal parties concerning programmatic
Expert written communication skills to prepare complex reports, briefings, position papers, policies, procedures, and
How to Apply
Applications will be accepted from all qualified internal and external applicants. Please send letter of interest addressing your experience in the major duties and responsibilities of the position and preferred location(s), detailed resume and bibliography, redacted SF-50 (for federal employees only), and transcript (with foreign credentials evaluation, if applicable) to the ORA Executive Recruitment and Scientific Staffing Committee, ORAExecutiveandScientificRecruitment@fda.hhs.gov. Applications will be accepted through June 12, 2023. Please reference DAES Statistician(Band C) in the subject line.
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organiza...tion/office-regulatory-affairs.
The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.
