Senior 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

• Master’s degree or PhD in Biostatistics, Statistics or related quantitative field, required
• Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates
• Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred
• Solid knowledge of statistical methodologies and clinical trial designs
• Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application
• Experience with regulatory support and interaction
• Experience providing statistical oversight of vendors and managing CRO collaborations
• Proven ability to manage multiple studies and timeline concurrently
• Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians
• Ability to work as a team and have skills to convince your position within cross-functional teams
• Demonstrated ability to communicate statistical concepts and results clearly and effectively
• Interest in and ability to learn clinical drug development processes
• Able to work independently with minimum supervision