Manager, Oncology Epidemiology

About the position At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Johnson & Johnson Innovative Medicine is seeking a Manager, Oncology Epidemiology to join our Global Epidemiology team. The preferred location for this position is either Raritan NJ, Titusville NJ, or Horsham PA. Consideration may also be given for Spring House PA, or Cambridge MA. (No fully remote option.) The Manager, Oncology Epidemiology role is accountable for working independently and supporting work across the Oncology Epidemiology team under the supervision of more senior members of the department. Primary responsibilities are: Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology study conduct across the clinical development program. Assist with conducting fit for purpose database and study feasibility assessments and executing analyses across the product cycle. Conduct literature reviews and synthesis; provide assistance to senior epidemiologists and clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs. 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 to product teams, and assist with disseminating technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team. Research natural history of diseases, both within and outside of existing electronic databases, 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. May work in cross departmental/sector committees, and or other efforts supporting J&J Innovative Medicine. 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. Responsibilities • Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology study conduct across the clinical development program. • Assist with conducting fit for purpose database and study feasibility assessments and executing analyses across the product cycle. • Conduct literature reviews and synthesis; provide assistance to senior epidemiologists and clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs. • 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 to product teams, and assist with disseminating technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team. • Research natural history of diseases, both within and outside of existing electronic databases, 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. • May work in cross departmental/sector committees, and or other efforts supporting J&J Innovative Medicine. • 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. Requirements • 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 2 years of hands-on experience is required. • At least 2 years of Epidemiology research experience is required. • Must have an understanding and the ability to interpret quantitative methods. Nice-to-haves • Experience with writing observational study protocols, proposals, and/or proposal requests, particularly the methods sections, is preferred. • A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is preferred. • Experience working with large administrative or medical records databases is preferred. • Applied pharmacoepidemiology research is preferred. • Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to the disease specific therapeutic area is preferred. • Experience working with health authorities is preferred. • Phase III/IV medicine development experience is preferred. • Experience working in a global environment is preferred. Benefits • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Apply tot his job