OneTrust

Associate Director, Benefit Risk/Patient Preference

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • Massachusetts • New Jersey • United States

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Salary

💰 $137,000 - $235,750 per year

Job Level

Senior

About the role

  • Leading structured benefit-risk assessments and patient preference studies including: Guiding clinical teams in benefit-risk assessment of products in development.
  • Leading preference studies to support products in development, including designing preference studies for internal advisory boards.
  • Applying structured patient preference, benefit-risk and decision analysis methods throughout the development lifecycle.
  • Contributing as an author to internal and regulatory documents (e.g. statistical analysis plans, submission documents).
  • Serving as an internal subject matter expert on these topics.
  • Keeping up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies and patient-focused drug development.
  • Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions, treatment access and providing guidance on use of real-world evidence in benefit-risk assessment.
  • Assist with internal benefit-risk process development and training, developing novel means to communicate and display preference and benefit-risk information, participating in external benefit-risk methodology and policy activities, authoring publications on their research and presenting at internal/external meetings.
  • Work closely with members of the Global Epidemiology, Clinical and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities.

Requirements

  • Education: Master’s degree in Decision Sciences, Health Economics, Epidemiology, Biostatistics, Public Health, or a related scientific discipline required; PhD or MD strongly preferred. MD applicants must also have a degree or certificate in one of these disciplines.
  • Required: A minimum of 5 years (3 year for PhD or MD) of hands-on experience in patient preference, benefit-risk, applied statistical or epidemiologic research
  • Knowledge of current academic/regulatory/industry trends in structured benefit-risk, preference studies and patient-focused drug development.
  • Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL) and/or experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique).
  • Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects.
  • Experience presenting technical topics to clinical/medical audiences.
  • Excellent communication (verbal and written) and interpersonal skills.
  • The ability to collaborate with all levels in a cross-functional team environment.
  • Strong problem-solving skills.
  • Strong self-management skills with a focus on timely completion of competing deliverables.
  • Preferred: Experience with tabular and graphical displays of benefit-risk data. Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA). Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses). Basic understanding of epidemiology methods. Experience with writing statistical methods sections of study proposals or statistical analysis plans. Experience working with Health Authorities. Experience working in a regulated biomedical/life science product development environment. Experience with analytical or statistical tools (e.g., R, SAS, Stata, MATLAB). Publication record or evidence of scholarship in patient preference studies, benefit-risk assessment or related topics.
Benefits
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

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

Hard skills
benefit-risk assessmentpatient preference studiesstatistical analysisepidemiologic researchdecision analysismulti-criteria decision analysisdiscrete choice experimentsbest-worst scalingthreshold techniquequantitative benefit-risk assessment
Soft skills
communication skillsinterpersonal skillsproblem-solving skillsself-management skillscollaboration skills
Certifications
Master’s degree in Decision SciencesMaster’s degree in Health EconomicsMaster’s degree in EpidemiologyMaster’s degree in BiostatisticsMaster’s degree in Public HealthPhDMD