Associate Director, Medical Affairs Biostatistics

Job Summary

Providing technical and operational support for post-approval clinical trials, the full-time remote Associate Director, Medical Affairs Biostatistics will manage biostatistics deliverables, collaborate with medical affairs teams, and ensure the integrity of statistical analyses and results interpretation.

Key responsibilities

• Provides statistical support for Medical Affairs research programs, publications, and evidence-generating activities
• Collaborates with R&D counterparts to support a broad range of activities within Medical Affairs
• Develops statistical analysis plans and interprets findings from various clinical studies

Required qualifications

• PhD in Statistics, Biostatistics, or Epidemiology with 5+ years of pharma/biotech experience, or MS with 8+ years of experience
• Knowledge of post-marketing study design and data-driven decision making
• Experience in designing and analyzing data from disease and product registry studies
• Hands-on statistical programming skills using R and/or SAS
• Familiarity with regulatory guidelines for drug development and CDISC standards