Clinical Trial Statistician

5 days ago

Mysore, Karnataka, India beBeeBiostatistics Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Biostatistics Leader

The biostatistics leader is responsible for developing and implementing statistical strategies and deliverables in support of clinical trials. This role contributes to the planning, execution, and interpretation of statistical analyses across development programs.

Main Responsibilities:

  • Lead biostatistical efforts for assigned studies and projects
  • Contribute to study design discussions, including protocol development and endpoint definition
  • Author and review Statistical Analysis Plans (SAPs) and oversee execution of statistical analyses
  • Provide statistical leadership in vendor oversight and manage deliverables
  • Communicate project status to management and escalate issues or risks as needed
  • Provide statistical input and review for clinical study reports and regulatory documents
  • Perform quality control of statistical outputs and maintain compliance with internal standards
  • Support regulatory interactions on statistical issues and provide applicable statistical strategies

Qualifications:

  • Bachelor's degree or higher 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 and knowledge of R and other programming languages
  • Solid knowledge of statistical methodologies and clinical trial designs
  • Strong understanding of CDISC standards and their application

Affiliate Benefits:

  • Excellent verbal and written communication skills
  • Able to work independently and as a team member
  • Demonstrated ability to communicate statistical concepts and results clearly

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