Associate Director, Biostatistical Consulting (United States)

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Requirements:

• Graduate degree in statistics, mathematics, life science, epidemiology, or healthcare.
• Minimum 12 years of relevant work experience and 6 years in drug development or clinical research.
• Good knowledge of GxP and familiarity with relevant regulations.
• Proficient in SAS and statistical programming languages.
• Strong communication, leadership, and problem-solving skills.

Responsibilities:

• Support statistical consulting for clinical program and protocol development.
• Provide input and responses to regulatory questions regarding statistical issues.
• Prepare and review statistical analysis plans, tables, listings, and figures for studies.
• Lead complex projects, manage communication with clients, and ensure study execution.
• Participate in regulatory meetings and contribute to statistical sections of clinical documents.