Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician to lead statistical strategy and oversight for clinical trial data analysis.

Key Responsibilities

• Oversee all statistical aspects of clinical programs from study design to regulatory submission
• Lead the development of clinical trial protocols, statistical analysis plans, and clinical study reports
• Collaborate with cross-functional teams to ensure compliance with regulatory standards and program objectives

Required Qualifications

• Bachelor's or Master's Degree in Statistics or Biostatistics with relevant experience (10+ years for Bachelor's, 8+ years for Master's)
• 5+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry
• Experience as a Lead Biostatistician on multiple concurrent projects
• Proficiency with CDISC STDM/ADaM standards
• Working knowledge of clinical research and regulatory guidelines