Principal Biostatistician Consultant - job 2 of 2

Job Summary

A company is looking for a Lead/Principal Statistician Consultant in Medical Affairs (remote).

Key Responsibilities:

• Serve as the lead biostatistician for Medical Affairs projects, including Phase IV studies and RWE analyses
• Provide statistical expertise in study design, protocol development, and reporting
• Collaborate with cross-functional teams and oversee statistical deliverables from CROs or external partners

Required Qualifications:

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related quantitative field
• Minimum of 8+ years (PhD) or 10+ years (Master's) of experience in the pharmaceutical, biotech, or CRO industry
• Strong experience in Medical Affairs, post-marketing studies, or real-world evidence
• Proficiency in SAS and/or R for statistical programming and analysis
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory frameworks