Data Science and Analytics Lead

1 day ago

Rajkot, Gujarat, India beBeeStatistical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Senior Biostatistician Role">

The Senior Biostatistician plays a crucial role in leading, developing, and overseeing statistical strategies to support the success of clinical trials. This individual contributes to planning, execution, and interpretation of statistical analyses across development programs, ensuring timely deliverables that meet regulatory standards.

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  • Lead biostatistics discussions, including protocol development, endpoint definition, and sample size estimation
  • Author and review Statistical Analysis Plans (SAPs) with mock tables, figures, and listings (TFLs)
  • Oversee statistical programming activities and manage vendor deliverables
  • Provide statistical input for clinical study reports, regulatory documents, and publications
  • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance
  • Deliver statistical presentations to internal and external stakeholders
  • Contribute to SOPs, Working Instructions (WIs), and internal guidelines
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Key Requirements:

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  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 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 and their application
  • Experience with regulatory support and interaction
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This position offers an exciting opportunity to work on cutting-edge projects, collaborate with cross-functional teams, and develop expertise in clinical drug development processes.

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