Janssen Global Services, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Patient Reported Outcomes to be located in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Global Services, LLC encompasses groups that provide leadership across critical business areas for Janssen including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; U.S. Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business Development.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Associate Director, Patient Reported Outcomes (PRO) Analytics works closely
with the Patient-Reported Outcomes (PRO) team and PRO Directors to facilitate
PRO-related activities in support of studies conducted for assigned products in
development in the Janssen R&D organization. The Associate Director is
responsible for managing PRO-related activities for assigned compounds in
development, and will focus on providing scientific expertise in measurement
and psychometric analytic issues across therapeutic areas. The Associate
Director will be responsible for assisting with or leading quantitative aspects
of several PRO programs. The Associate Director provides background information
on competitor drug PRO research, conducts PRO literature searches, conducts
qualitative research, works with the clinical team to incorporate PRO
instruments into clinical studies, oversees analyses and publications, and
generally represents the PRO function in clinical working groups and other
- Partner with the PRO Lead to provide the clinical teams with the information necessary for the appropriate incorporation of PRO measures in clinical studies.
- Partner with internal teams responsible for vendor collaborations, clinical operations, and data management to ensure appropriate PRO data capture methods (including ePRO) and processes are implemented.
- Oversee psychometric analyses and work with statisticians on PROs included in protocols, statistical analysis plans, and clinical study reports.
- Participate in preparing relevant PRO sections of documentation and communication for regulatory agencies in support of submission activities.
- Conduct ad hoc analyses and provide interpretation for relevant PRO sections of dossiers for HTA submissions.
- Conduct analyses in the preparation of abstracts and manuscripts presenting PRO results from clinical studies.
- Evaluate and manage projects with researchers and PRO vendors external to the company, including but not limited to validation studies and quantitative analyses.
- Manages budgets and contracts for projects; helps ensure that knowledge gained from PRO projects and activities are captured in a shared electronic PRO repository.
- Minimum of a Master’s Degree in an appropriate field (Psychology, Psychometrics, Biostatistics, Sociology, Health Economics, Epidemiology, Public Health, Health Services Research, etc.), and a PhD is preferred.
- A minimum of 6-7 years of relevant work experience in biostatistics or quantitative sciences is required.
- A strong background in psychometric analysis is preferred.
- Understanding statistical modeling and programming skills in SAS or SPSS are required.
- An understanding of the research and development process is preferred.
- Project management experience is required.
- The successful candidate will have superior communication and strong interpersonal skills demonstrated through working within cross-functional teams. Must be capable of independently leading projects.
- This position requires up to 15% yearly travel (domestic and international).
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-Pennsylvania-Horsham
Janssen Global Services, LLC (6085)