Principal Biostatistician Consultant- Hybrid (NJ/PA/DE)

Added
17 hours ago
Type
Full time
Salary
Salary not provided

Related skills

r sas biostatistics clinical trials regulatory

๐Ÿ“‹ Description

  • Lead statistics for drug development and post-approval programs.
  • Design protocols and perform sample size calculations with the project team.
  • Coordinate statistical and programming support; manage contractors/CROs.
  • Serve as lead statistician for clinical studies and liaise with study teams.
  • Draft/review SAPs and associated mock TLFs; ensure accuracy across outputs.
  • Support regulatory interactions, submissions, and interpretation of results.

๐ŸŽฏ Requirements

  • M.S. or Ph.D. in Statistics or Biostatistics required.
  • 4+ years (Ph.D.) or 8+ years (M.S.) pharma industry experience.
  • Experience with regulatory agencies (FDA, MHRA, EMEA).
  • SAS, R, and other stats software for endpoint analysis.
  • Lead clinical studies and manage CROs/external vendors.
  • Ability to work independently and mentor junior staff.

๐ŸŽ Benefits

  • Hybrid work arrangement with sponsor exposure.
  • Global CRO environment with career development.
  • Flexible, collaborative culture and trainings.
  • Mentoring and leadership opportunities.
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