Associate Scientist or Scientist, Psychometrics, Patient-Centered Outcomes (PCO) 

Location: Remote US/UK/DE/NL

Job Summary

Our Associate Scientist/Scientist, Psychometrics leads and supports the design and execution of quantitative studies. Via strong team collaboration, they will partner with a diverse group of clients to execute projects related to measurement development and validation. With an expertise in psychometrics, this scientist will focus especially on employing methods that pull from classical test and modern validity theories to assess measurement properties of clinical outcome assessments (COAs) as part of our growing Health Economics and Outcomes Research (HEOR) consulting practice.

Our Scientists and Associate Scientists take responsibility for a wide range of scientific research activities, with a primary focus on quantitative study design and data analysis. They also participate in consultation on endpoint strategy and COA data interpretation, with a focus on evidentiary expectations of key stakeholders: patients and families; health care providers; regulatory agencies; and payor/health technology assessment (HTA) bodies. The successful candidate will be familiar with patient-focused drug development, the valuable role measurement science plays in medical product development, as well as a desire to move the field forward through thoughtful innovation.

The PCO team is passionate about conducting applied research that brings benefits to patients and their families. We understand the relevance of measuring the right patient outcomes and patient experience and are committed to OPEN Health’s values when working on diverse PCO projects.

Essential Duties & Responsibilities

As part of the OPEN Health PCO team, you’ll be responsible for activities such as:

• Designing, analyzing, and reporting of both interventional and non-interventional studies evaluating clinical outcomes assessments (COAs): patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome (ClinRO), and performance outcome (PerfO) assessments
• Serving as an expert analyst to provide input regarding COAs
• Leading programming and interpretation of advanced psychometric analysis, including:
  • Psychometric analyses
    • Modern psychometric methods, including factor analysis, item response theory, tests of local dependence, differential item/test functioning, scoring evaluation
    • Classical test theory, including internal consistency, test-retest reliability, responsiveness
    • Meaningful score difference/range estimation using current regulatory-recommended methods
  • Linear/generalized linear mixed models
  • Latent variable models
  • Survival models (including mixture and joint models)

• Advising on or supporting the development of  COA-focused strategies for client interactions/submissions with health authorities including regulatory agencies (e.g., FDA, EMA) and HTA bodies

• Interacting with federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with occasional interaction with other international regulators

• Developing study documents such as study proposals, protocols, statistical or psychometric analysis plans, COA dossiers, technical reports, and study presentations
• Reporting, drafting and finalizing technical reports, regulatory briefing packages, and manuscripts
• Building client relationships, which involves communication with both federal grant and pharmaceutical industry funding sponsors

Experience, Skills, and Qualifications

• Master’s degree or doctoral-level degree (PhD, MD, PharmD) in biostatistics, psychometrics, quantitative psychology, educational measurement, or a related field
• Knowledge of advanced psychometric methods including factor analysis and item response theory/Rasch analysis
• Experience performing modern psychometric methods and classical test theory analyses in statistical software
• Fluency in at least one primary programming language (R strongly preferred)
• Experience in a comparable industry, ideally from research organization or pharma environment
• Strong attention to detail and superior communication skills (both written and verbal)
• Strong analysis interpretation and organization skills, including the ability to prepare and present relevant summaries of complex materials to non-analytic audiences
• Comfort in a client-facing role
• Experience mentoring, guiding, and providing hands-on support to less-experienced analysts is desirable
• Experience in clinical outcomes assessments (COAs, including, but not limited to PROs)
• Proactive, efficient, and adaptable with the ability to learn quickly
• Experience with submissions to regulatory agencies is desirable
• Demonstrated collaboration and communication skills

It is anticipated that the candidate’s role will include progressively increasing responsibility within our project teams, with leadership opportunity.

Travel Requirements

• Work responsibilities may require domestic or international travel averaging up to approximately 1 day per month for project meetings, data collection, or scientific conference participation.