Director, Psychometrics, Patient Centered Outcomes

1 month ago


Baltimore, Maryland, United States Open Health Full time

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.The psychometrics team supports studies of instrument development, psychometric evaluation (classical and modern methods), and analysis of CObased study endpoints (e.g., longitudinal modelling, survival analysis, trial exploration, missing data & intercurrent event adjustment).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.Overseeing and advising on the development of statistical and validation analysis plans and conducting psychometric and/or quantitative analyses to meet the study objectivesMSc or PhD in Biostatistics or Psychometrics, or a relevant science, for example in Health economics, Public Health, Epidemiology, Pharmacoeconomics, or PsychologyStrong experience in patient centered outcomes research: COA instrument development/psychometric validation, quantitative analysis of CObased clinical study endpoints, regulatory dossier development and submissionsOPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns.



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