Statistical Data Scientist

7 days ago

Mumbai, Maharashtra, India beBeeStatistical Full time ₹ 18,00,000 - ₹ 24,00,000

Job Title: Statistical Programmer Lead

The Senior Statistical Programmer is responsible for leading statistical programming support for multiple clinical projects using SAS. Key responsibilities include delivering key 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.
  • Develops statistical programming 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.
  • Delivers key regulatory-compliant output based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.
  • Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-functional programming activities, and programming validation as needed.

Requirements:

  • A bachelor's degree plus 4 years 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 the ability to process scientific and medical data.
  • Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.

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