Remote (Country) Full-time

Unknown Company is hiring a Principal Biostatistician

About the Role

ICON plc is hiring a Principal Biostatistician to provide statistical leadership for small-to-medium sized, simple-to-highly complex Phase I-III clinical trials within our Oncology account group. You will be responsible for input on statistical components across the study lifecycle, from protocol development to final reporting.

What You'll Do

  • Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies.
  • Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies.
  • Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports.
  • Program using SAS and/or R for inferential statistics.
  • Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients.
  • Participate in bid defense meetings and make presentations at marketing meetings with prospective clients.
  • Mentor or provide support to junior statisticians.
  • Lead or partake in initiatives to improve internal processes or create new guidance.

What We're Looking For

  • Master's degree OR PhD in Biostatistics, Statistics, or a related field.
  • 9+ years of biostatistical experience with a Master’s degree OR 7+ years of biostatistical experience with a PhD.
  • Experience leading Phase I-III Oncology studies, including client facing responsibilities, timeline management, and resource oversight.
  • Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications).
  • Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies.
  • Effective written and oral communication skills with demonstrated leadership ability.
  • Ability to prioritize with strong time management skills.

Nice to Have

  • Experience working in a clinical research organization.

Technical Stack

  • SAS
  • R

Team & Environment

You will join a Full-Service Biostatistics team within the Oncology account group.

Benefits & Compensation

  • Various annual leave entitlements
  • A range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme, TELUS Health
  • Life assurance
  • Flexible country-specific optional benefits (e.g., childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments)

Work Mode

This is a remote position open to candidates in the United States.

ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Required Skills
SASRClinical TrialsStatistical AnalysisCDISC StandardsRegulatory SubmissionsProtocol DevelopmentStatistical ProgrammingBiostatisticsStudy Design
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Posted 8 months ago