Data Analysis Expert

1 day ago

Bengaluru, Karnataka, India beBeeBiostatistician Full time ₹ 1,00,80,000 - ₹ 2,01,60,000

Job Summary

The Senior Biostatistician is a key member of our biostatistics team, responsible for providing high-quality statistical expertise and support to clinical trials.

Key Responsibilities
  • Collaborate with biostatisticians, statistical programmers, clinical data managers, and other teams to ensure the accuracy and reliability of statistical deliverables.
  • Perform and oversee quality control (QC) of data displays with inferential statistics, ensuring that results are accurate and consistent.
  • Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications.
  • Author or review statistical analysis plans, ensuring that they meet regulatory requirements and are aligned with study goals.
  • Coordinate with other biostatisticians, statistical programmers, and data managers to prepare, conduct, and review statistical analyses.
  • Ensure the accuracy of final statistical deliverables, including tables, listings, and figures.
  • Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
  • Perform validation of analysis variables and statistical outputs, ensuring that they meet regulatory requirements.
  • Participate in cross-functional study-related activities and team meetings, collaborating with other departments to ensure seamless execution.

Required Qualifications:

  • Master's degree in statistics or related fields with 6+ years of industry experience as a Statistician.
  • PhD degree with 3+ years of postgraduate experience in Biostatistics or equivalent.
  • Ability to lead projects and manage team members, working collaboratively, effectively, and productively in diverse organization structures.
  • Solid statistics background and training, working knowledge of advanced statistical methodologies, and SAS programming skills.
  • Good understanding of drug development and experiences with clinical trial data analyses/preparation for submissions.
  • Good knowledge and understanding of regulatory guidelines.

Education and Experience Required

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