Senior Quantitative Researcher

15 hours ago

Gulbarga, Karnataka, India beBeeBiostatistician Full time ₹ 1,80,00,000 - ₹ 2,50,00,000
Job Summary

The Senior Biostatistician plays a pivotal role in spearheading statistical strategies and deliverables for clinical trials.

This position contributes to the planning, execution, and interpretation of statistical analyses across development programs under the guidance of the Head of Biostatistics.

Key Responsibilities:
  • 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.
Requirements:
  • Masters degree or PhD in Biostatistics, Statistics, or related quantitative field.
  • 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.

This opportunity presents a chance for an experienced biostatistician to take on complex projects and contribute to the success of clinical trials.

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