Senior Biostatistician

3 weeks ago

Delhi, 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 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

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