Director, Psychometrician-PCOR/Digital Health

As a Director/Psychometrician you will support our Patient-Centered Outcomes Research and Digital Health (PCOR-DH) needs within HEOR/Medical Affairs. Building our expertise in psychometrics, we are expected to develop and advise on measurement strategies across our portfolio. Our measurement strategies will evaluate patient experience data (PED) in terms of how patients feel, function and survive striving to identify meaningful aspects of health and concepts of interest in conceptual models, define treatment benefit from the patient perspective, and establish patient-centered measurement strategies using eCOAs and other Digital Health Technologies. Collaborating with HEOR therapeutic areas, we develop and validate de novo COAs and other DHTs for, patient-relevant meaningful endpoints supporting product approval, labeling, patient access, and medical differentiation.

This can be a remote role but needs to be based in the US.

A typical day may include the following:
Understanding patients experiences in target populations and develop PCOR measurement strategies.
Assessing literature and existing Clinical Outcomes Assessments (COAs), conducting gap analyses, recommend and implement activities to address those gaps.
Providing technical support around instrument development.
Designing, overseeing, and implementing psychometric studies/analysis plans for validation of COAs.
Ensuring COAs are appropriately implemented in clinical trials, reviewing relevant clinical protocol sections and conducting COA training.
Serving as a measurement science/psychometric expert and knowledge of PCOR guidance documents. These will include the FDAs Patient Focused Drug Development (PFDD) guidances, EMAs Patient-Reported Outcomes (PRO) and Health-Related Quality of Life reflection papers.
Supporting teams in COA drug labeling strategies, including developing questions to agencies, producing/reviewing COA evidence dossiers for submissions, and attendance to meetings.
Analyzing, interpreting and communicating psychometric results internally and produce high quality psychometric technical reports for regulatory review.
Contributing to regulatory documents (e.g., briefing books, COA dossiers), and support teams in drug labeling strategies.
Contributing to scientific literature in the fields of psychometric and health outcomes research publications and presentations at conferences.
Maintaining awareness of industry standards and regulatory requirements and psychometric fields within drug development, communicating new and changing standards.

This may be for you if you:
Recognized within the psychometric field in psychometric methods including both classical test theory and item response theory.
Want to have an impact on patient lives
Can work optimally in a rapid response environment.
Have provided solutions to unusual complexity requiring a high level of resourcefulness, creativity and innovativeness.

To be considered you are required to have a Doctoral degree (preferably PhD) in psychometrics, or a related subject area. A minimum of 7+ years experience in pharma/biotech, consulting, or academic settings in PCOR-DH in the application of psychometric methods and results to inform patient-relevant endpoints.

Additional requirements include:
Effectively communicate psychometric methods (classical and modern) and aiding interpretation of results to technical and non-technical collaborators
Strong statistical programming skills (e.g., r, SAS, SPSS).
Proven track record of peer-reviewed publications in psychometrics.
Significant interaction with FDA, EMEA and other regulatory agencies.
Experience educating different target audiences on psychometric methods and outputs.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)