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 Duties

Primary duties and responsibilities include, but are not limited to:

• Collaborating with business development, marketing, and other service areas to build greater awareness of OHGs PCO team capabilities
• Leading the development of proposals and proactively engaging in seeking new opportunities
• Managing and mentoring of mid-level and junior team members
• Overseeing the design and execution of COA studies that align with international scientific standards and regulatory authorities recommendations
• Overseeing and advising on the development of statistical and validation analysis plans and conducting psychometric and/or quantitative analyses to meet the study objectives
• Leading or advising 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

Required 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
• 8+ years of 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
• Proven track record of 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 a number of different projects and work to deadlines
• Strong experience in business development and ability to generate organic growth opportunities
• Well-developed problem-solving skills and a genuine interest in delivering high-quality deliverables
• History of effective leadership of a global team
• Highly proficient in MS365 including Word, Excel, PowerPoint, Teams and Outlook

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.