Lead Statistical Data Analyst

2 days ago

Pune, Maharashtra, India beBeeStatistical Full time ₹ 1,59,23,200 - ₹ 1,98,04,000
Statistical Programmer Role

This role involves working as a fully embedded statistical programmer with a global pharmaceutical client, driving the next generation of patient treatment.

Responsibilities:

  • Generate SDTM, ADaM specifications, datasets, reviewer's guide, and define XML files for multiple studies.
  • Develop SAS programs which generate datasets, complex listings, tables including those with descriptive and standard inferential statistics in collaboration with a statistician, and complex graphs.
  • Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and or R programs tailored to clinical development program needs.
  • Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet pre-specified timelines.
  • Support preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.
  • Understand and follow FDA regulations which affect reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions.
  • Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
  • Participate in development of CRFs, edit check specifications, and data validation plans.
  • Provide review and/or author data transfer specifications for external vendor data.
  • Collaborate with internal and external functions, e.g., CROs, software vendors, clinical development partners, etc., to ensure meeting project timelines and goals.
  • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.

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