Director, Psychometrics, Patient Centered Outcomes (PCO)
OPEN Health
Job Description:Director – Psychometrics, Patient Centered Outcomes (PCO)Our Director – Psychometrics, Patient-Centered Outcomes (PCO) is responsible for overseeing and advising on the development and execution of clinical outcome assessment (COA) studies. Specifically, these studies will focus on supporting our clients’ COA strategy in clinical trials and non-interventional/observational studies. The psychometrics team supports studies of instrument development, psychometric evaluation (classical and modern methods), and analysis of COA-based study endpoints (e.g., longitudinal modelling, survival analysis, trial exploration, missing data & intercurrent event adjustment).The majority of the work in this team is regulatory-focused. Therefore, the role involves generating evidence for submission to federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and occasional interaction with other international regulators. Experience with regulatory agencies is essential for this role.Essential DutiesPrimary duties and responsibilities include, but are not limited to:
Required Experience, Skills, and Qualifications
About OPEN HealthOPEN 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.What we offer:As a global organization, OPEN Health is committed to supporting our employees and their families through a comprehensive benefits program
If we sound like the sort of business environment in which you would thrive, then we would love to hear from you.
United Kingdom
Sat, 03 Aug 2024 05:18:00 GMT
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