Biostatistics Associate Director

Job Summary

A company is looking for an Associate Director, Biostatistics.

Key Responsibilities

• Lead statistical activities for clinical studies, ensuring regulatory compliance and statistical integrity
• Contribute to study design, author and review statistical sections of study documents, and participate in project meetings
• Develop and propose innovative statistical methodologies to enhance study efficiency and accuracy

Required Qualifications

• PhD in Statistics or Biostatistics with at least 5 years of experience in clinical trials; 8 years required for a Master's degree
• Experience with NDA/BLA/MAA activities and regulatory interactions
• Proven experience as a study lead statistician in cross-functional teams
• Familiarity with ICH guidelines and regulatory authority guidance
• Proficient in SAS and R, with knowledge of CDISC standards