Senior Biostatistician

2 days ago

India Advanced Clinical Full time

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 projectsLead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimationAuthor 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 partnersProvide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverablesRegularly 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 publicationsPerform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standardsLead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerationsDeliver statistical presentations to internal and external stakeholders, or regulatory authorities as neededContribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelinesGood knowledge of CDISC Standards, including SDTM, ADaMStay current with emerging statistical methodologies and evolving clinical trial practicesPerform other duties/tasks as required or assignedMinimum Education, Knowledge, Skills, and Abilities Master’s degree or PhD in Biostatistics, Statistics or related quantitative field, requiredMinimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidatesProficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferredSolid knowledge of statistical methodologies and clinical trial designsStrong understanding of CDISC standards (e.g., SDTM, ADaM) and their applicationExperience with regulatory support and interaction Experience providing statistical oversight of vendors and managing CRO collaborationsProven ability to manage multiple studies and timeline concurrentlyExcellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticiansAbility to work as a team and have skills to convince your position within cross-functional teamsDemonstrated ability to communicate statistical concepts and results clearly and effectivelyInterest in and ability to learn clinical drug development processesAble to work independently with minimum supervision

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