Associate Director Of Biostatistics

Associate Director of Biostatistics Overview

• The Associate Director of Biostatistics leads statistical strategies for clinical development programs, ensuring scientific rigor and operational efficiency.
• Contribute to therapeutic area strategies, overseeing statistical components and ensuring high scientific integrity across projects.
• Provide leadership in study design, statistical analysis, and interpretation to support clinical development goals.
• Collaborate with cross-functional teams, offering guidance on complex statistical issues and regulatory compliance.
• Oversee statistical activities and deliverables from CROs, ensuring quality and adherence to timelines.
• Work in a hybrid environment with relocation assistance available for eligible candidates.
• Opportunity to contribute to innovative clinical trials and therapeutic strategies in a dynamic organization.

Associate Director of Biostatistics Key Responsibilities & Duties

• Provide statistical leadership and guidance for clinical development programs, including study design and analysis.
• Serve as the statistical lead on cross-functional study teams, addressing complex statistical challenges.
• Design clinical trials, calculate sample sizes, and develop randomization plans.
• Write statistical sections for study protocols, analysis plans, and study reports.
• Review study protocols, CRFs, database structures, and annual reports for statistical accuracy.
• Oversee CRO statistical activities, ensuring quality and timely implementation of analysis plans.
• Maintain documentation of statistical analyses and related supportive documents.

Associate Director of Biostatistics Job Requirements

• PhD in Statistics, Biostatistics, or related field with 5+ years of relevant experience.
• Master’s degree in Statistics, Biostatistics, or related field with 8+ years of relevant experience.
• Proficiency in SAS programming and other statistical software such as R.
• Advanced knowledge of CDISC standards and their application to projects.
• Strong oral and written communication skills for effective collaboration and reporting.
• Experience in leading statistical strategies and ensuring regulatory compliance.
• Ability to oversee and manage statistical deliverables from CROs effectively.