Associate Director of Biostatistics

Job Summary

A company is looking for an Associate Director, Biostatistics.

Key Responsibilities

• Oversee statistical activities for multiple clinical studies and manage statistical efforts
• Contribute to clinical protocol development and author statistical analysis plans
• Provide oversight of CROs for outsourced statistical activities and ensure quality control of results

Qualifications

• PhD in statistics or related field with at least 6 years of clinical trial experience (or MS with at least 9 years)
• Knowledge of statistical methods for clinical trials and FDA, EMA, and ICH regulations
• Proficient in statistical programming (SAS required, R preferred)
• Experience with trial design software (e.g., EAST)
• Experience with regulatory submissions, including BLAs and MAAs, is a plus