Operations Research Analyst

FDA in Silver Spring, MD

  • Industry: Scientific Research - Economics
  • Type: Full Time
  • Compensation: $90,150.00 - 161,520.00 / Year*
position filled
This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here: CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law. This position is located on the Program Evaluation and Implementation Staff (PEIS), Office of Program and Strategic Analysis (OPSA) within the Office of Strategic Programs (OSP) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). OPSA is responsible for quantitative and qualitative data analysis, business process analysis and improvement, and program evaluation to support senior management decisions. OPSA provides consultation services to Center Offices in developing and implementing proposals for key strategic initiatives and priorities, evaluating the impact of operations and policies on external stakeholders, and in conducting evaluation studies to inform Center strategy and policy position on emerging issues in drug regulation. The primary purpose of this role is to conduct analyses, evaluations and implementations of CDER programs and initiatives. This work will have a direct effect on decisions affecting major Center regulatory policies and programs. The incumbent will utilize tools and techniques and other appropriate analytic methodologies from disciplines such as evaluation, management science, and economics. As an Operation Research Analyst, some of your duties will consist of: Contributing to the conceptualization of complex analyses, including framing and identification of the study. Selecting the appropriate techniques for quantitative and qualitative data collection and analysis, collecting that data, and interpreting it into findings and recommendations for senior management. Conducting needs assessments and contributing to the design and execution of complex evaluation plans to assess the implementation and impact of CDER programs and policies. Designing surveys, conducting interviews and facilitating focus groups to gather quantitative data. Coding and analyzing complex qualitative data using data analysis software (e.g. NVIVO). Utilizing process mapping and process analysis in the design of program and/or project implementation plans. Communicating and collaborating with scientific and regulatory officials in the FDA. Providing succinct and informative written and oral reports and presentations on complex analyses to the immediate supervisor and as needed to senior Center management. Qualifications: Applicants must have a degree in operations research; or at least 24 semester hours in a combination of operations research, mathematics, probability, statistics, mathematical logic, science, or subject-matter courses requiring substantial competence in college-level mathematics or statistics. At least 3 of the 24 semester hours must have been in calculus. Desired Experience: Knowledge and skill in applying the principles, concepts, tools and methodology of operations research and analysis and improvement, value-stream analysis, decision analysis, economics, mathematics or statistics. Skill in identifying necessary relevant information given the study questions and skill in applying conventional methods to gather and analyze such information. Knowledge of written and oral communication techniques required to prepare and deliver reports and presentations on study results and other critical data and information. TO APPLY Please send a current CV/resume and cover letter electronically to Normica.Izzardfda.hhs.gov by April 18, 2020.

* Estimated salary


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