Biostatistics Consultant

Job Summary

A company is looking for a Statistical Consultant, Biostatistics.

Key Responsibilities

• Serve as a lead statistician and manage statistical efforts for multiple clinical studies
• Contribute to clinical protocol development and author statistical analysis plans
• Support regulatory interactions and submissions, and prepare publications

Required Qualifications

• PhD in statistics or a related field with at least 12 years of relevant clinical trial experience
• In-depth knowledge of statistical methods for clinical trials
• Thorough understanding of FDA, EMA, and ICH regulations and guidelines
• Extensive experience with trial design and clinical development plans
• Proficient in statistical programming (SAS required, R is a plus)