OneTrust

Manager, Epidemiology – Neuroscience

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Horsham • 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 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.
  • Collaborate with various functional teams, especially Global Medical Safety. Align global and local Epidemiology strategies and to enhance communication and networking within the department and within the company.

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 3 years of hands-on 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.
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
epidemiologystatistical methodsquantitative methodspharmacoepidemiologystatistical programmingRstudy designliterature reviewsdata synthesisrisk assessment
Soft Skills
collaborationcommunicationnetworkingconsultingeducationtechnical writingpresentation skillsorganizational skillsproblem-solvingteamwork
Certifications
PhD in epidemiologyMD with training in EpidemiologyMaster’s degree in related field