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