Social Scientist/Psychometrician

Social Scientist/ Psychometrician

This position is being filled under a stream-lined 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 this authority.

The mission of the Center for Devices and Radiological Health (CDRH or Center) is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. The Office of Strategic Partnerships and Technology Innovation (OST or Super Office) provides leadership for all scientific collaborative and emerging technology related activities at CDRH. We represent CDRH with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products. The Office of Equity and Innovative Development (OEID or Office) provides leadership and strategic direction in health equity, patient science, and innovation activities at the Center.

Duties/Responsibilities

Serves as a Social Scientist/Psychometrician in the Division of Patient Centered Development (DPCD). Serves as an expert analyst to provide input regarding patient-reported outcomes (PRO) and other Clinical Outcome Assessments (COAs). Responsible for evaluating a variety of complex study tools, endpoint assessments, and patient-centered outcome issues to support medical device development and evaluation, including through therapeutic clinical trials.

Social Science/Psychometric Consultation

As the technical authority in the specialized scientific area of patient science (which includes patient-reported outcomes, patient-generated health data, and patient preference information), the incumbent performs critical reviews of scientific or technical procedures, methodologies, and investigations for scientific and regulatory policy implications and impact on overall scientific activities and priorities in areas that require extensive interpretation. Serves as the recognized expert authority in planning, conducting, and evaluating patient science studies and approaches to using them, as well as where critical problems need to be resolved and existing methods are inadequate, making it extremely difficult to design studies and gather reliable data. The incumbent explores innovative evaluation methods and tools to assess the benefits and risks of these methods while providing expertise in the formulation of patient science studies’ development, utilization, and interpretation in medical product evaluation.

Serves as an expert advisor and technical authority providing liaison and consultation services related to social science on endpoint development, validation, and application in medical device studies. Collaborates with physicians, healthcare professionals, and regulatory and technical experts to ensure that all relevant medical product matters are addressed in relation to study tools, endpoints or applications of patient science issues and concerns. Provides leadership and expert advice and assistance to the CDRH management in defining Social Science analysis issues, conducting analysis of programs, formulating policy and strategy, making project recommendations, conceptualizing new programs or in redesigning ongoing ones, etc., to ensure that they address current and pressing issues.

Social Science/Psychometric Technical Resource

Represents DPCD in working meetings with industry representatives, members of other government agencies, and others to provide expert advice on COA-related issues to support medical device labeling claims and study designs. Analyzes, formulates, and develops ideas, concepts, and methodologies for new or revised policies, procedures, and systems for designing, implementing, and evaluating COAs worldwide.

Conducts research in strategy, design techniques, and methodology. Identifies concepts and ideas that have proved successful and develops alternative concepts and techniques for use in a variety of situations. Assesses strategic objectives, program and project design, and methodologies used to determine that they will accomplish established objectives. Considers differences among patients and the types of factors that influence COAs. Analyzes outcomes by utilizing qualitative and quantitative approaches. Utilizes scholastic research that encompass principles, theories, and findings in industrial/organizational psychology, psychometrics, experimental design/evaluation methodology, education, and training technology, and/or cognitive psychology to modify, revise, improve or create programs and projects.

Develops and validates measurements that capture psychological aspects of patients, including symptoms, feelings, perceptions, functions, and perspectives; also brings that expertise to bear on digital health technologies that may capture real world data about the daily lived experience of patients. Reviews and performs an in-depth analysis of published literature and study results to develop tools for COA data collection to support study design features, endpoints, and labeling claims. These tools and related study endpoints or patient preference elicitation issues are broad in scope and affect a significant portion of regulated industry, as well as the public. Based upon the information derived from COA-related issues and reviews, the incumbent provides expert consultation and advice to sponsors and medical device development tool subcommittees.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1.Scientific, Technical, and Professional Fields for Social Science Series 0101.

2.Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

How to Apply

How to Apply: Submit resume or curriculum vitae, with cover letter and unofficial transcripts by August 10, 2024, to CDRHRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: CDRH/OST/OEID/DPCD - Social Scientist