Related skills
r sas biostatistics clinical trials regulatory๐ 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.
๐ฏ 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.
๐ 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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