Associate Director, Biostatistics Consultant – Oncology (Remote)

📋 Description

• Provide statistical leadership and strategic guidance for oncology clinical development programs
• Lead the development and review of statistical analysis plans (SAPs), statistical methodologies
• Provide expertise in oncology endpoints, including overall survival (OS), progression-free survival
• Oversee the statistical analysis of clinical trial data, including time-to-event analyses
• Review and provide oversight of clinical study reports (CSRs), tables, listings, figures (TLFs)
• Support regulatory submissions and interactions with health authorities, including the FDA, EMA

🎯 Requirements

• PhD in Statistics, Biostatistics, or a closely related quantitative discipline; a Master’s degree
• Extensive experience in biostatistics within the pharmaceutical, biotechnology, or contract
• Strong experience supporting oncology clinical trials, preferably across multiple phases of
• Demonstrated expertise in survival analysis, time-to-event endpoints, clinical trial design
• Thorough understanding of oncology efficacy endpoints, response assessment criteria such as RECIST
• Experience preparing and reviewing SAPs, CSRs, regulatory submission documents, and integrated