Manager Epidemiology

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Manager, Epidemiology. The preferred position location includes Horsham, PA; Titusville, NJ or Raritan, NJ. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company. The Manager, Epidemiology will have the opportunity to work independently, and in this role will also function under the supervision of more senior members of the department, primarily providing support to the Neuroscience franchise. The primary responsibilities of the Manager will be to: Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology strategy and study conduct Work closely with colleagues in the Observational Health Data Analytics group when defining research questions, developing epidemiological protocols, and implementing solutions Provide epidemiological and/or statistical consulting, education and support, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team Work will include, both within and outside of existing electronic databases, researching natural history of diseases to understand the inherent risks associated with the indication; statistical risk assessment; using historical clinical trial data and other observational databases to develop an understanding of potential safety issues for new medications, and indications, based on experience with related compounds. Conduct literature reviews and synthesis; provide assistance to teams with study design; and identify and evaluate data resources to meet therapeutic needs Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management Plans and the development of formal guidance for use of RWE for Regulatory Decision Making. Qualifications Qualifications PhD in epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 3 years of hands-on experience is required At least 3 years of Epidemiology research experience is required Must have an understanding and the ability to interpret quantitative methods Experience with writing protocols in general and particularly the statistical methods sections of observational study proposals and/or proposal requests is required Experience working with large administrative or medical records databases is preferred At least 1 year of applied pharmacoepidemiology research is preferred Experience with statistical programming (e.g., R) is preferred Experience in the neuroscience therapeutic area preferred Experience working with health authorities is preferred Phase III/IV medicine development experience is preferred Experience working in a global environment is preferred A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required; author position commensurate with prior academic training and working environments. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206020162W