OneTrust

Director, Oncology Epidemiology

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Raritan • Massachusetts • New Jersey • United States

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Salary

💰 $164,000 - $282,900 per year

Job Level

Lead

About the role

  • accountable for working independently while functioning under the supervision of more senior members of Global Epidemiology
  • responsible for oversight of various projects and initiatives in areas of epidemiology and real-world evidence research
  • leading research projects, drafting protocols and statistical analysis plans
  • overseeing the analysis of real-world data (including, but not limited to, insurance claims data, hospital billing data, EMRs, curated oncology datasets, registries) and the dissemination of scientific information through technical reports, presentations, and publications in peer-reviewed literature
  • Identify research study needs, drafting proposals and protocols, contributing to real-world evidence (RWE) strategy and study conduct across the therapeutic area portfolio
  • Work closely in collaboration with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, conducting analyses, and interpreting and communicating evidence to internal and external stakeholders
  • Participate in various multi-disciplinary matrix teams to address issues raised by product teams/regulatory agencies where real-world data (RWD)/RWE can inform decisions
  • Provide epidemiological and/or statistical consulting and support to compound/product teams, and disseminate technical information through reports, presentations, and publications in peer-reviewed literature as agreed by the team
  • assess feasibility of fit-for-purpose RWD; research natural history of diseases to understand background event rates in the indicated population expected with standard of care; perform statistical risk assessments; use historical clinical trial data and other data sources to contextualize potential safety issues for new medications; support benefit-risk assessments throughout the product lifecycle; design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans
  • supporting efforts for the Office of the Chief Medical Officer and cross-sector collaborations, as prioritized
  • Promote the use of standardized tools to support real world evidence generation across functions utilizing RWE as part of the Integrated Evidence Generation Plan
  • Keep up to date with changes in the external environment, including working through professional society and public-private consortia to advocate as a subject matter expert, regarding RWE guidance/framework 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 6 years of hands-on experience is required.
  • At least 5 years of Epidemiology research experience is required.
  • Understanding and the ability to apply and interpret quantitative methods is required.
  • Experience writing observational study protocols, proposals, and proposal requests, particularly the methods sections is required.
  • Experience working with large administrative or medical records databases is required.
  • Background in the epidemiologic landscape of oncology including related conditions and therapies is required.
  • A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required.
  • Experience working with health authorities is preferred.
  • Product development experience in the pharmaceutical industry is preferred.
  • Experience working in a global, cross-functional team environment is preferred.
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
epidemiologyreal-world evidence (RWE)statistical analysisquantitative methodsobservational study protocolsdata analysisrisk assessmentsPharmacovigilancesignal strengtheningclinical trial data
Soft Skills
independent workcollaborationcommunicationleadershipproject oversightconsultingproblem-solvingstakeholder engagementtechnical writingpresentation skills
Certifications
PhD in EpidemiologyMD with training in EpidemiologyMaster’s degree in related field