Biostatistics Director Consultant

Job Summary

Biostatistics Director Consultant, an experienced professional responsible for providing strategic statistical leadership for clinical development programs, collaborating with various teams and stakeholders, and ensuring high-quality statistical deliverables in a part-time capacity.

Key Responsibilities

• Provide statistical leadership for Phase I-IV clinical trials across multiple therapeutic areas
• Oversee statistical analyses and interpretation of clinical trial data
• Support regulatory submissions and ensure compliance with ICH-GCP and regulatory guidelines

Required Qualifications

• Master's or PhD in Statistics, Biostatistics, Mathematics, or related quantitative discipline
• Minimum 10-15 years of experience in Biostatistics within CRO, pharmaceutical, or biotech industries
• Strong knowledge of clinical trial methodology and regulatory requirements
• Hands-on experience supporting global regulatory submissions
• Expertise in SAS and understanding of CDISC standards (SDTM/ADaM/TLFs)