Leading Statistician for Clinical Trials

2 days ago

Belgaum, Karnataka, India beBeeBiostatistician Full time ₹ 16,00,000 - ₹ 24,20,000
Senior Biostatistician Job Description

The Senior Biostatistician plays a pivotal role in leading and developing statistical strategies and deliverables to support clinical trials. Under the guidance of senior management, 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

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