Manager, Oncology Epidemiology
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Raritan • Massachusetts • New Jersey • United States
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Salary
💰 $117,000 - $201,250 per year
About the role
- 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
- 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
- At least 2 years of Epidemiology research experience
- 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
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Applicant Tracking System Keywords
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Hard Skills & Tools
epidemiologyquantitative methodsobservational study protocolsstatistical risk assessmentpharmacoepidemiologydata analysisliterature reviewsclinical trial datadatabase assessmentsscientific communications
Soft Skills
collaborationcommunicationconsultingeducationpresentation skillstechnical writingproblem-solvingorganizational skillscross-departmental teamworkadaptability
Certifications
PhD in EpidemiologyMD with training in EpidemiologyMaster’s degree in related field