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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 with other international regulators. Experience with regulatory agencies is essential for this role.
Essential Duties & Responsibilities:
- Leading the development of proposals and proactively engaging in seeking new opportunities
- Overseeing the design and execution of COA studies that align with international scientific standards and regulatory authorities recommendations with guidance and support from senior leads
- Overseeing and advising on the development of statistical and validation analysis plans and conducting psychometric and/or quantitative analyses to meet the study objectives
- Advising or supporting on the COA-focused strategy for client interactions/submissions with regulatory agencies (FDA, EMA)
- Presenting research findings to clients and other external stakeholders, including presentations at scientific congresses
- Overseeing the development of study documents such as study proposals, protocols, statistical or psychometric analysis plans, technical reports, and study presentations
- Opportunity to mentor junior team members
- Opportunity to collaborate with business development, marketing, and other service areas to build greater awareness of OPEN Health Groups PCO team capabilities
Experience, Skills, and Qualifications
- MSc or PhD in Biostatistics or Psychometrics, or a relevant science, for example in Health economics, Public Health, Epidemiology, Pharmacoeconomics, or Psychology
- Experience in a consulting, pharmaceutical, or industry setting
- Strong experience in patient-centered outcomes research: COA instrument development/psychometric validation, quantitative analysis of COA-based clinical study endpoints, regulatory dossier development and submissions
- Previous experience interacting with regulatory Agencies (FDA, EMA, PMDA)
- Fluency/proficiency in at least one of the following programming languages: R or SAS
- Extensive working knowledge of relevant regulatory guidance on COAs
- Strong communicator (both written and verbal) with attention to detail and accuracy
- Strong organizational and project management skills, including the ability to juggle several different projects and work to deadlines
- Experience in business development and thought leadership
- Well-developed problem-solving skills and a genuine interest in delivering high-quality deliverables
- Highly proficient in MS365 including Word, Excel, PowerPoint, Teams and Outlook
Travel Requirements
- 10% potential 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.
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 health insurance programs 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, then we would love to hear from you.
