Hybrid Manager, Oncology Epidemiology

at Johnson & Johnson

• Job title: Manager, Oncology Epidemiology
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: $117,000 - $201,250 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Raritan, United States

About the role

• Manager of Oncology Epidemiology supporting clinical study conduct at Johnson & Johnson. Involves assisting with research study needs, proposals, and conducting epidemiology studies.

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.
• 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

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• 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
• Work, Personal and Family Time - up to 40 hours per calendar year