Lead Statistician - Clinical Trials

About the Role

The Senior Biostatistician leads statistical strategies and deliverables in support of clinical trials under the guidance of Head of Biostatistics, ensuring high-quality timely deliverables that meet regulatory and scientific standards.

Key Responsibilities :

• Serves as biostatistics leader for assigned studies and projects, overseeing all aspects of data analysis and interpretation.
• Leads study design discussions, including protocol development, endpoint definition, and sample size estimation, to ensure effective and efficient trial execution.
• Authors and reviews Statistical Analysis Plans (SAPs), including mock tables, figures, and listings, to ensure accuracy and compliance with internal standards.
• Oversees execution of statistical analyses per SAP in collaboration with programming and CRO partners, ensuring seamless integration and delivery of results.
• Provides statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables to meet project timelines and budget.
• Communicates project status to management, escalates issues or risks in a timely manner, and provides regular updates on progress.
• Provides statistical input and review for clinical study reports, regulatory documents, and publications, ensuring high-quality and compliant outputs.
• Performs quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards, identifying areas for improvement and implementing corrective actions as needed.
• Leads regulatory interactions on statistical issues, providing applicable statistical strategies to handle clinical and regulatory considerations, and ensuring compliance with relevant regulations and guidelines.
• Delivers statistical presentations to internal and external stakeholders or regulatory authorities as needed, effectively communicating complex statistical concepts and findings.