Expert Statistical Programmer

2 days ago

Vadodara, Gujarat, India beBeeStatistical Full time ₹ 1,37,91,300 - ₹ 2,09,28,900

Job Title: Statistical Programmer Expertise

Description

Our company is seeking a highly skilled Senior Statistical Programmer to provide expert statistical programming support for multiple clinical projects using SAS. This role involves delivering regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff.

Main Responsibilities:

  • Lead statistical programming support for multiple clinical research study projects or study teams
  • Develop statistical programming with SAS (Base and Macros) and provide expert consultation to projects across the company including statistical programming methodology
  • Ensure sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures
  • Provide 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
  • Develop programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and may contribute to standardization efforts
  • Write well-documented, efficient, and high-quality code, conduct code review, support cross-functional programming activities, and programming validation as needed
  • Keep abreast of current statistical programming techniques to ensure the adoption of sound methodologies
  • Present statistical programming topics internally and may present at external conferences
Requirements

To be successful in this role, you will need:

  • 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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