Associate Director of Biostatistics

Job Summary

A company is looking for an Associate Director, Biostatistics.

Key Responsibilities

• Act as the main point of contact for Statistics related to designated compounds/indications
• Provide statistical input and scientific advice to clinical development teams and regulatory authorities
• Ensure consistency of statistical methods and oversee trial-related work in accordance with regulatory standards

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 and biostatistics processes
• Proven ability to manage multiple complex projects in a technical capacity