Senior Quantitative Analyst

2 days ago


Palakkad, Kerala, India beBeeBiostatistician Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Summary

The Senior Biostatistician plays a pivotal role in the clinical trial team, overseeing statistical strategies and deliverables in support of R&D sponsored clinical trials.

Under the guidance of Head of Biostatistics, this position contributes to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Key Responsibilities:
  • Leads or contributes to study design discussions, including protocol development, endpoint definition, and sample size estimation
  • Authors and reviews Statistical Analysis Plans (SAPs), including mock tables, figures, and listings
  • Oversees and ensures the execution of statistical analyses per SAP in collaboration with programming and CRO partners
  • Provides statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
  • Regularly communicates project status to management and escalates issues or risks in a timely manner
  • Provides statistical input and review for clinical study reports, regulatory documents, and publications
Requirements:
  • Masters 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


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