Senior Quantitative Expert

4 days ago

Ajmer, Rajasthan, India beBeeStatistician Full time ₹ 20,00,000 - ₹ 25,00,000
Lead Statistician for Clinical Trials

The successful candidate will play a pivotal role in the development and implementation of statistical strategies and deliverables, contributing to the success of our R&D sponsored clinical trials.

Key Responsibilities:
  • Collaborate with study design teams on discussions including protocol development, endpoint definition, and sample size estimation
  • Author and review Statistical Analysis Plans (SAPs), incorporating mock tables, figures, and listings
  • Oversight of statistical analyses per SAP in collaboration with programming and CRO partners
  • Direct statistical programming activities and manage vendor deliverables
  • Communicate project status to stakeholders 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 regulatory interactions on statistical issues and provide applicable statistical strategies
  • Deliver statistical presentations to stakeholders
  • Maintain knowledge of CDISC Standards, including SDTM, ADaM
  • Stay current with emerging statistical methodologies and evolving clinical trial practices

Requirements

  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field
  • Minimum 8 years of experience in clinical trial biostatistics; Proficiency in SAS programming language
  • Solid understanding of statistical methodologies and clinical trial designs
  • Strong understanding of CDISC standards (e.g., SDTM, ADaM)
  • Excellent verbal and written communication skills

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