Data Science Lead

3 days ago

Tirupati, Andhra Pradesh, India beBeeBiostatistician Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Biostatistician Opportunity

The role of Senior Biostatistician is crucial in driving and implementing statistical strategies to support clinical trials.

Key Responsibilities
  • Lead biostatistics efforts for assigned studies and projects, ensuring timely deliverables meet regulatory and scientific standards.
  • 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.
  • Oversee statistical analyses per SAP in collaboration with programming and CRO partners.
  • Provide statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables.
  • Communicate project status to management, escalating issues or risks as needed.
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications.
  • Perform quality control of statistical outputs to ensure accuracy and compliance.
  • Lead regulatory interactions on statistical issues and provide applicable statistical strategies.
  • Deliver statistical presentations to internal and external stakeholders.
Requirements
  • A master's degree or PhD in Biostatistics, Statistics, or a 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, with knowledge of R and other programming languages preferred.
  • Solid knowledge of statistical methodologies and clinical trial designs.
  • Strong understanding of CDISC standards and their application.
  • Experience with regulatory support and interaction.
  • Ability to manage multiple studies and timelines concurrently.
  • Excellent verbal and written communication skills.

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