Lead Statistical Programmer Expert

23 hours ago

Nagpur, Maharashtra, India beBeeDataAnalyst Full time ₹ 8,00,000 - ₹ 17,50,000
Senior Statistical Programmer

Job Summary:

A senior statistical programmer is responsible for providing lead statistical programming support for multiple clinical projects using SAS and expert consultation across the company. The key responsibilities include delivering regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff.

Key Responsibilities:

  • Provides lead statistical programming support for multiple clinical research study projects or study teams.
  • Delivers statistical programming development with SAS (Base and Macros) and provides expert consultation to projects across the company including statistical programming methodology.
  • Ensures sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research which involve CDISC standards and analysis data sets or production of standard and custom tables listings and figures.
  • Provides key deliverables based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.
  • Develops programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and may contribute to standardization efforts.
  • Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-functional programming activities, and programming validation as needed.
  • Keeps abreast of current statistical programming techniques to ensure adoption of sound methodologies.
  • Presents statistical programming topics internally and may present at external conferences.

Requirements:

  • A bachelor's degree plus 4 years of statistical programming experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment, education in a scientific discipline preferred.
  • Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and ICH guidance and recommendations) in Clinical Research.
  • Good analytical skills with ability to process scientific and medical data.
  • Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.

Benefits:

  • Opportunity to work on multiple clinical projects.
  • Chance to develop expertise in statistical programming methodologies.
  • Collaborative work environment.

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