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

Required Qualifications

• PhD in statistics or a related field with at least 6 years of relevant clinical trial experience, or MS with at least 9 years
• In-depth knowledge of FDA, EMA, and ICH regulations and guidelines
• Proficient in statistical programming (SAS required, R is a plus)
• Experience with ADaM and SDTM
• Experience with trial design software (e.g., EAST) is preferred