Senior Biostatistical Expert

5 days ago

Anantapur, Andhra Pradesh, India beBeeBiostatistics Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Senior Biostatistician

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The position of a Senior Statistician is to provide statistical support and leadership in the design, analysis, and interpretation of clinical trials. The successful candidate will collaborate with cross-functional teams, including Biostatisticians, Statistical Programmers, Clinical Data Managers, and Clinical Research Associates, to ensure high-quality, reliable statistical expertise.

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Key responsibilities include:

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  • Collaborating with sponsors' teams to develop statistical analysis plans (SAPs) and protocols;
  • Performing and overseeing quality control (QC) of data displays with inferential statistics;
  • Maintaining project administration files, including annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications;
  • Authoring or reviewing SAPs and ensuring the accuracy of final statistical deliverables;
  • Providing guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures;
  • Ensuring validation of analysis variables and statistical outputs;
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Qualifications

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To be successful in this role, candidates must have:

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