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

Associate Scientist/Scientist, Psychometrics, Patient-Centered Outcomes (PCO) - Remote, US-based position

Job Summary

Our Scientists in Patient-Centered Outcomes lead and support the design and execution of quantitative and mixed methods (qualitative and 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, you 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 take responsibility for a wide range of scientific research activities, primarily focusing on quantitative study design and data analysis. They also participate in consultation on endpoint strategy and COA data interpretation, focusing on evidentiary expectations of key stakeholders: patients and families, health care providers, regulatory agencies, and payor/health technology assessment (HTA) bodies. The ideal 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. This role is anticipated to include progressively increasing responsibility within our project teams, with leadership opportunities.

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

• 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
• Exploring the potential of digital health technologies (DHTs), including wearable and sensor-based devices as measurement tools and methods for interpreting DHT-collected data
• Advising or supporting on the COA-focused strategy for client interactions/submissions with health authorities, including regulatory agencies (eg, 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

Opportunity to 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 

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

Travel Requirements

Up to 5% Global Travel

About OPEN Health

OPEN Health unites deep scientific knowledge with wide-ranging specialist expertise to unlock possibilities that improve health outcomes and patient wellbeing. Working in partnership with our clients, we embrace our different perspectives and strengths to deliver fresh thinking and solutions that make a difference. 

OPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns. 

As a leading HEOR consulting firm, OPEN Health provides evidence-based insights that drive decision-making in the healthcare industry. Our multidisciplinary team of experts collaborates to deliver innovative solutions to clients worldwide.

What we offer:

As a global organization, OPEN Health is committed to supporting our employees and their families through a comprehensive benefits program

• Competitive pay, generous paid vacation and holidays, and more across all our locations
• 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

If we sound like the sort of business environment in which you would thrive, we would love to hear from you.