Statistical Expert

21 hours ago

Ajmer, Rajasthan, India beBeeBiostatistician Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Biostatistician Job Opportunity

The role of Senior Biostatistician involves leading the development, implementation, and oversight of statistical strategies and deliverables in support of clinical trials.

This position contributes to planning, execution, and interpretation of statistical analyses across various development programs, ensuring high-quality and timely deliverables that meet regulatory and scientific standards.

Main Responsibilities:
  • Lead biostatistics efforts for assigned studies and projects
  • Participate in 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 statistical analysis execution 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
  • Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
  • Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed
  • Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines
  • Familiarity with CDISC Standards, including SDTM, ADaM

Requirements and Qualifications:

  • Bachelor's degree in Statistics, Mathematics, or related quantitative field. Master's degree preferred
  • Minimum 8 years of experience in clinical trial statistics; preference given to candidates with advanced degrees or additional certifications
  • Proficiency in statistical programming languages such as SAS, R, or Python
  • Solid understanding of statistical methodologies and clinical trial designs
  • Excellent communication skills, with ability to explain complex concepts to non-technical audiences
  • Able to work independently and collaboratively within a team environment

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