FDA Job Vacancies – Data Scientist (Psychometrician)

Job Description:

CDRH is seeking an experienced, innovative, and team oriented human data scientist who is dedicated to improving health outcomes and the quality of life of patients through the advancement of therapeutic and diagnostic medical devices. In this position, you will conduct comprehensive qualitative and quantitative psychometric analysis on the use and impact of medical devices and combination products, regulated by the Center, across the entire patient spectrum. As a critical member of the PSE multidisciplinary team, you will report directly to the Assistant Director and will be responsible for providing expert evaluation of clinical studies submitted by industry to include design, methodology, endpoints, assessment tools, and software. You will also evaluate the consistency and validity of industry reported information, as well as conduct real-world data assessment of medical device usage, patient-reported outcomes s, clinical and caregiver reported outcomes, as well as performance outcomes. You will review advertisements, and labeling related to the design and intended use of medical devices in patients. You will also design, coordinate, and conduct studies to develop or modify clinical outcome assessment instruments.

Job Responsibilities:

• Utilize your expertise in human data science to develop and implement psychometric analysis plans to evaluate clinical study data, to include https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.clinical-outcome-assessment/ (such as patient-reported outcomes), evidence to support their measurement properties, compliance information, and outcomes related to the therapeutic and diagnostic benefits of medical devices, diagnostic equipment, and combination products, based on intended use.
• Serve as the voice in human data science and collaborate with colleagues across the Office, Center and Agency to develop guidance documents, policies, and standards regarding the use of clinical outcome assessments in the evaluation of medical devices, diagnostic equipment, and combination products.

Job Requirements:

• Knowledge and experience with applying psychometric analysis methods such as classical test theory, item response theory, and item factor analysis. Experience in developing, applying, and/or validating psychometric instruments and patient-centered outcomes.
• Evidence of a strong commitment to data quality, validation, and transparency.
• Demonstrated proficiency in the use of statistical and psychometric software.
• Contribute to recommendations which speak to the safety, efficacy, and reliability medical products or procedures, based on validated study data.
• Demonstrated proficiency in written and verbal communication skills, as well as team work

Job Details:

Company: Food and Drug Administration

Vacancy Type: Full Time

Job Functions: Healthcare

Job Location: Washington, DC, US

Application Deadline: N/A

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