Associate Director, Biostatistical Consulting

View full description

Requirements:

• Graduate degree in statistics, mathematics, life science, epidemiology, or healthcare.
• Minimum 12 years of work experience and 6 years in drug development or clinical research.
• Good knowledge of GxP and familiarity with relevant regulations like GDPR, HIPAA.
• Proficient in SAS and sample size software, with strong technical, analytical, and problem-solving skills.
• Excellent organizational skills, detail-oriented, and capable of managing multiple tasks.

Responsibilities:

• Support and provide statistical consulting services for clinical program and protocol development.
• Contribute to client executive decisions and regulatory submissions, interacting with regulatory bodies.
• Prepare statistical analysis plans and reviews to ensure document quality.
• Lead projects by setting timelines, communicating with clients, and collaborating with teams.
• Function as the lead statistician for studies and manage budget oversight.