Data Insights Specialist

3 days ago

Guntur, Andhra Pradesh, India beBeeBiostatistics Full time US$ 1,30,000 - US$ 1,70,000
Senior Statistician Role

As a Senior Statistician, you will collaborate with biostatisticians, statistical programmers, clinical data managers, clinical research associates, and sponsors' teams to deliver high-quality, reliable statistical expertise and support.

The role involves performing and overseeing quality control (QC) of data displays with inferential statistics. Additionally, you will conduct QC analysis on datasets prepared by others, maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications),

Key Responsibilities:

  • Provide statistical leadership and support to clinical trials.
  • Participate in cross-functional study-related activities and team meetings.
  • Perform sample size calculations when needed.
  • Author or review statistical analysis plans.
  • Coordinate with other biostatisticians, statistical programmers, and data managers to prepare, conduct, and review statistical analyses.
  • Ensure the accuracy of final statistical deliverables.
  • 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.
  • Participate in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualifications and Skills:

  • 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 and work collaboratively, effectively, and productively in diverse organizational 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.

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