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Senior Psychometrics and Patient-Centered Outcomes Lead
2 months ago
We are seeking a highly experienced and skilled Director, Psychometrics and Patient-Centered Outcomes Strategist to join our team at OPEN Health. As a key member of our Psychometrics and Patient-Centered Outcomes team, you will be responsible for overseeing and advising on the development and execution of clinical outcome assessment (COA) studies.
Key Responsibilities- Study Development and Execution: Oversee the design and execution of COA studies that align with international scientific standards and regulatory authorities' recommendations.
- Statistical and Validation Analysis: Oversee and advise on the development of statistical and validation analysis plans and conduct psychometric and/or quantitative analyses to meet the study objectives.
- Regulatory Strategy: Lead or advise on the COA-focused strategy for client interactions/submissions with regulatory agencies (FDA, EMA).
- Team Management: Manage and mentor mid-level and junior team members.
- Business Development: Collaborate with business development, marketing, and other service areas to build greater awareness of OHGs PCO team capabilities and lead the development of proposals and proactively engage in seeking new opportunities.
- Education: MSc or PhD in Biostatistics or Psychometrics, or a relevant science, for example in Health economics, Public Health, Epidemiology, Pharmacoeconomics, or Psychology.
- Experience: Experience in a consulting, pharmaceutical, or industry setting, with a strong background in patient-centered outcomes research, COA instrument development/psychometric validation, quantitative analysis of COA-based clinical study endpoints, regulatory dossier development and submissions.
- Skills: 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.
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.
As a global organization, OPEN Health is committed to supporting our employees and their families through a comprehensive benefits program, including competitive pay, generous paid vacation and holidays, and health insurance programs across all our locations.
