Senior Manager Biostatistician Consultant

New
C
ClinChoiceBiotechnology Pharmaceutical
United StatesContractManager
Salary not disclosed
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Job Details

Experience
PhD +4 years or MS +9 years clinical trial experience
Required Skills
R

Requirements

  • MS or PhD in Statistics or Biostatistics
  • PhD +4 years or MS +9 years of clinical trial experience in biotech or pharmaceutical industry
  • Hands-on experience with Phase I/II/III clinical trials
  • Proficiency in SAS programming
  • Excellent oral and written communication skills
  • R programming experience (desirable)
  • Experience with regulatory submissions (desirable)

Responsibilities

  • Contribute to the design of early and late-stage clinical protocols across multiple therapeutic areas
  • Draft clinical protocols and amendments
  • Develop and write statistical analysis plans (SAPs)
  • Perform statistical analyses for interim and final reports for regulatory submission
  • Design, analyze, and report integrated summaries for safety and efficacy
  • Provide statistical contributions during study team meetings
  • Organize and schedule study deliverables in collaboration with Statistical Programmers and Data Managers
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