Principal Biostatistician Consultant

Job Summary

To support Medical Affairs and Real World Evidence activities, the remote Principal Biostatistician Consultant will provide statistical leadership in the design, analysis, and interpretation of observational studies while collaborating with cross-functional teams.

Key responsibilities

• Partner with medical teams for publication strategies and provide statistical expertise in analyses using external control and causal inference methods
• Contribute to manuscripts, abstracts, and presentations while reviewing protocols for real-world evidence studies
• Collaborate with HEOR to align analyses with HTA agency expectations and perform quality reviews of statistical analyses

Required qualifications

• M.S. or Ph.D. in Biostatistics or equivalent with at least 5 years of experience in pharmaceutical or biotechnology sectors
• Prior experience working with medical affairs and commercial
• Good understanding of meta-analyses and causal inference methodologies
• Familiarity with regulatory guidance on RWE and HTA requirements
• Strong statistical programming skills using relevant statistical software