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Chief Data Strategist

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Hubli, Karnataka, India beBeeBiostatistician Full time ₹ 20,00,000 - ₹ 25,00,000

Lead Biostatistician

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The Senior Biostatistician role entails strategic leadership and the development of statistical methodologies to support R&D sponsored clinical trials. Key objectives include leading biostatistics initiatives, contributing to study design discussions, authoring Statistical Analysis Plans (SAPs), and ensuring the execution of statistical analyses.

">Key Responsibilities:
  • Biostatistical leadership for assigned studies and projects
  • Study design discussions, protocol development, endpoint definition, and sample size estimation
  • Author and review SAPs, including mock tables, figures, and listings (TFLs)
  • Oversee statistical programming activities and manage deliverables from vendors
  • Regularly communicate project status to management and escalate issues or risks in a timely manner
  • 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
  • Regulatory interactions on statistical issues and provide applicable statistical strategies
  • Deliver statistical presentations to stakeholders
  • Maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines

Requirements:

  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field
  • Minimum 8 years of experience in clinical trial biostatistics (MS-level candidates); Minimum 6 years (PhD-level candidates)
  • Proficiency in statistical programming in SAS, knowledge of R and other programming languages preferred
  • Solid knowledge of statistical methodologies and clinical trial designs
  • CDISC standards (SDTM, ADaM) and their application
  • Experience with regulatory support and interaction, vendor oversight, and CRO collaborations
  • Proven ability to manage multiple studies and timelines concurrently

We are looking for an expert who can drive statistical excellence in our organization. If you have a strong background in biostatistics and want to take on new challenges, apply now