Associate Director of Biostatistics

Job Summary

A company is looking for an Associate Director, Biostatistics.

Key Responsibilities

• Represents biostatistics at cross-functional team meetings and contributes to clinical development plans
• Writes statistical sections of clinical trial protocols and prepares statistical analysis plans
• Collaborates with various teams on trial design and provides statistical guidance on ongoing trials

Required Qualifications

• Ph.D. in Biostatistics or Statistics with at least 7 years of pharmaceutical biostatistics experience, or MS with at least 10 years of relevant experience
• Experience programming in SAS
• Interest in biology and biological processes, including RNAi
• Experience in clinical development through Phase 3 (NDA submission)
• Understanding of ICH GCP and industry practices and standards