Associate Director of Biostatistics

Job Summary

A company is looking for an Associate Director, BioStatistics.

Key Responsibilities

• Act as the main point of contact related to Statistics for designated compound/indication
• Provide statistical input to clinical development strategies and trial designs
• Ensure compliance with regulatory requirements and oversee statistical deliverables

Required Qualifications

• Master's or PhD in a statistical discipline
• 8+ years of relevant experience in statistical analysis and drug development
• Experience with FDA, EMA, and ICH guidance for drug development
• Familiarity with regulatory submissions including BLAs and CDISC requirements
• Proven ability to manage multiple complex projects in a technical capacity