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Senior Psychometrics Lead

2 months ago

London, Greater London, United Kingdom OPEN Health Full time
{"h1": "Associate Director - Psychometrics, Patient-Centered Outcomes (PCO)", "p": "At OPEN Health, we are seeking an experienced Associate Director to lead our Psychometrics, Patient-Centered Outcomes (PCO) team. As a key member of our team, you will oversee the development and execution of clinical outcome assessment (COA) studies, focusing on supporting our clients' COA strategy in clinical trials and non-interventional/observational studies.

Your expertise will be essential in generating evidence for submission to federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as occasional interaction with other international regulators.

Key Responsibilities:

* Lead the development of proposals and proactively engage in seeking new opportunities
* Oversee the design and execution of COA studies that align with international scientific standards and regulatory authorities' recommendations
* Oversee and advise on the development of statistical and validation analysis plans and conduct psychometric and/or quantitative analyses to meet the study objectives
* Advise or support on the COA-focused strategy for client interactions/submissions with regulatory agencies (FDA, EMA)
* Present research findings to clients and other external stakeholders, including presentations at scientific congresses
* Oversee the development of study documents such as study proposals, protocols, statistical or psychometric analysis plans, technical reports, and study presentations

Requirements:

* 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

What We Offer:

* 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 you are a motivated and experienced professional looking to make a meaningful impact in the healthcare industry, we encourage you to apply for this exciting opportunity.", "h2": "About OPEN Health"}