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 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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