Associate Scientist, Psychometrics

Summary

Join OPEN Health as an Associate Scientist/Scientist in Patient-Centered Outcomes (PCO)! Lead and support the design and execution of quantitative and mixed-methods studies, collaborating with clients on measurement development and validation. Employ psychometric methods to assess clinical outcome assessments (COAs). Take responsibility for a wide range of scientific research activities, focusing on quantitative study design and data analysis. Contribute to endpoint strategy and COA data interpretation, interacting with stakeholders including regulatory agencies. This role offers increasing responsibility and leadership opportunities within project teams. The PCO team is dedicated to applied research benefiting patients and families, aligning with OPEN Health's values.

Requirements

• Master’s degree, doctoral-level degree (PhD, MD, PharmD) in biostatistics or psychometrics, epidemiology, pharmacoeconomics, psychology or relevant field
• Experience in a comparable industry, ideally from research organization or pharma environment
• Strong attention to detail and superior communication skills (both written and verbal)
• Solid analytical and organizing skills; including the ability to prepare and present relevant summaries of complex materials
• Comfort in a client-facing role
• Experience mentoring, guiding, and providing hands-on support to less-experienced analysts
• Fluency in at least one primary programming language (R or SAS)
• Advanced proficiency in MS365 including Word, PowerPoint, Outlook, Teams with a focus on Excel proficiency
• Experience in clinical outcomes assessments (COAs, including, but not limited to PROs)
• Proactive, efficient, and adaptable, with the ability to learn quickly

Responsibilities

• Design, analyze, and report on 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
• Explore the potential of digital health technologies (DHTs), including wearable and sensor-based devices as measurement tools and methods for interpreting DHT-collected data
• Advise or support on the COA-focused strategy for client interactions/submissions with health authorities, including regulatory agencies (e.g., FDA, EMA) and HTA bodies
• Interact with federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with occasional interaction with other international regulators
• Develop study documents such as study proposals, protocols, statistical or psychometric analysis plans, COA dossiers, technical reports, and study presentations
• Employ various analytic methods, including: Linear models, Generalized linear models, Linear/generalized linear mixed models, Latent variable models, Mixture models, Survival models (including mixture and joint models), Psychometric analyses, Classical Test Theory (e.g., internal consistency, test-retest, responsiveness, meaningful change estimation), Modern psychometric methods (e.g., EFA, Item Response Theory (IRT), tests of Local Dependence (LD), Differential Item/Test Functioning (DIF/DTF), Scoring evaluation, Item-level descriptives)
• Report, draft, and finalize technical reports, regulatory briefing packages, and manuscripts
• Build client relationships, which involves communication with both federal grant and pharmaceutical industry funding sponsors

Preferred Qualifications

• Experience with submissions to regulatory agencies
• Demonstrated collaboration and communication skills

Benefits

• Competitive pay
• Generous paid vacation and holidays
• Ongoing training and development opportunities which foster and shape your individual career path
• An active and growing commitment to bettering the communities our employees call home through our Corporate Social Responsibility program
• The opportunity to thrive in a global, collaborative environment while working every day to improve health outcomes and patient wellbeing
• Diverse, inclusive culture that encourages you to bring your whole self to work