Senior Statistician I

2 days ago

Hyderabad, Telangana, India Capgemini Full time ₹ 12,00,000 - ₹ 18,00,000 per year

Your Role

We are seeking an experienced and collaborative Senior Statistician I to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory compliance of statistical deliverables. The Senior Statistician will also oversee quality control processes and contribute to the development of statistical analysis plans and datasets.

In this role, you will:

  • Provide statistical leadership and support for clinical trials, ensuring high-quality deliverables.
  • Participate in cross-functional study-related activities and team meetings.
  • Perform sample size calculations and author or review statistical analysis plans (SAPs).
  • Coordinate with Biostatisticians, Statistical Programmers, and Data Managers to prepare, conduct, and review statistical analyses.
  • Ensure the accuracy and integrity of final statistical outputs and deliverables.
  • Guide and supervise programmers in developing analysis specifications and programming/validation of tables, listings, figures (TLFs)/ CDISC Standards/SDTM/ADAMs
  • Validate analysis variables/statistical outputs for consistency/compliance.
  • Conduct quality control (QC) of data displays/analysis datasets prepared by others.
  • Maintain project administration files including protocols, annotated CRFs, SAPs, annotated shells, programming/QC rules, tracking logs, communications.
  • Participate in internal meetings/contribute to Biostatistics Development Team initiatives.
  • Statistical Methodology:Advanced statistical techniques, sample size estimation, inferential statistics
  • Programming: Proficiency in SAS, Macros Base SAS, clinical data analysis tools

Your Profile

  • Masters degreein Statistics or related field with6+ years of industry experience
  • PhDin Biostatistics or related field with3+ years of postgraduate experience
  • Proven abilityto lead projects and manage cross-functional teams
  • Strong foundationin statistical methodologies and SAS programming
  • Experiencewith clinical trial data analysis and regulatory submissions

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