Career Opportunities

1 day ago


Pune, Maharashtra, India beBeeBiostatistician Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Biostatistician Role

The Senior Biostatistician drives success in clinical trials through strategic statistical leadership. This pivotal role spearheads planning, execution, and interpretation of statistical analyses across development programs.

Key Responsibilities:
  • Lead biostatistics for assigned studies and projects, ensuring timely execution of statistical analyses per plan.
  • Participate in study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • Author and review Statistical Analysis Plans (SAPs), incorporating mock tables, figures, and listings.
  • Oversee statistical programming activities, managing deliverables and vendor oversight.
  • Communicate project status to management and escalate issues or risks promptly.
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications.
  • Perform quality control of statistical outputs to ensure accuracy and compliance with internal standards.
  • Lead or support regulatory interactions on statistical issues, providing applicable strategies.
  • Deliver statistical presentations to internal and external stakeholders or regulatory authorities as needed.
Required Qualifications:
  • Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field.
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates.
  • Proficiency in statistical programming in SAS; knowledge of R and other programming languages preferred.
  • Solid understanding of statistical methodologies and clinical trial designs.
  • Strong knowledge of CDISC standards (e.g., SDTM, ADaM) and their application.
  • Experience with regulatory support and interaction.
  • Ability to work as a team and convince position within cross-functional teams.
  • Excellent verbal and written communication skills, explaining statistical concepts to non-statisticians.


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