Data Strategist

5 days ago

Mumbai, Maharashtra, India beBeeBiostatistician Full time ₹ 1,58,93,930 - ₹ 2,42,73,300
Senior Biostatistician Role

The role of Senior Biostatistician is pivotal in driving the statistical strategies and deliverables for our clinical trials. Working under the guidance of the Head of Biostatistics, this position contributes to the planning, execution, and interpretation of statistical analyses across development programs.

Key Responsibilities:

  • 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

Requirements:

  • 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 timelines 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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