Biostatistics Director Consultant

Added
less than a minute ago
Type
Full time
Salary
Salary not provided

Related skills

sas biostatistics clinical trials cdisc regulatory submissions

📋 Description

  • Provide statistical leadership for Phase I–IV trials across multiple therapeutic areas.
  • Lead SAPs, protocol statistics, and randomization specifications.
  • Oversee analyses and interpretation of trial data; ensure timely outputs.
  • Collaborate with programming teams to deliver outputs and support regulatory submissions.
  • Mentor junior statisticians; contribute to proposals and business growth.
  • Ensure ICH-GCP compliance and adherence to SOPs.

🎯 Requirements

  • Master’s or PhD in Statistics, Biostatistics, Mathematics, or related field.
  • 10–15 years in Biostatistics within CRO, pharma, or biotech.
  • Strong knowledge of clinical trial methods and regulatory requirements.
  • Hands-on experience supporting global regulatory submissions.
  • Expert in SAS and CDISC SDTM/ADaM/TLFs.
  • Experience leading sponsor interactions and cross-functional teams.
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