Clinical Trials Statistician Leader

Senior Biostatistician

This role oversees statistical strategy and deliverables for clinical trials, contributing to planning, execution, and interpretation of statistical analyses to ensure high-quality, timely deliverables meeting regulatory and scientific standards.

Key Responsibilities :

• Lead biostatistics for assigned studies and projects
• Collaborate on study design discussions, including protocol development, endpoint definition, and sample size estimation
• Author and review Statistical Analysis Plans (SAPs)
• Execute statistical analyses per SAP in collaboration with programming and CRO partners
• Provide statistical leadership in vendor oversight
• Regularly communicate project status to management and escalate issues or risks
• Offer statistical input and review for clinical study reports, regulatory documents, and publications
• Ensure quality control (QC) of statistical outputs

Requirements :