Principal Biostatistician

The Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client’s R&D sponsored clinical trials. Under the guidance of Head of Biostatistics, this role contributes to the planning, execution and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Essential Functions

• Serve as biostatistics leader for assigned studies and projects
• Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation
• Author and review Statistical Analysis Plans (SAPs), including mock tables, figures and listings (TFLs)
• Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners
• Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
• Regularly communicate project status to management and escalate issues or risks in a timely manner
• Provide statistical input and review for clinical study reports, regulatory documents, and publications
• Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
• Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
• Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed
• Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelines
• Good knowledge of CDISC Standards, including SDTM, ADaM
• Stay current with emerging statistical methodologies and evolving clinical trial practices
• Perform other duties / tasks as required or assigned

Minimum Education, Knowledge, Skills, and Abilities

Minimum of 6 years for PhD-level candidates