Associate Director - Psychometrics, Patient-Centered Outcomes (PCO) - US
OPEN Health
N/A
Associate Director – Psychometrics, Patient-Centered Outcomes (PCO)
Job Summary
Our Associate Director – Psychometrics, Patient-Centered Outcomes (PCO) oversees, advises, and supports 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...