Statistical Programmer Expert

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeStatistical Full time ₹ 8,00,000 - ₹ 12,50,000

Senior Statistical Programmer Role

This is a senior level statistical programming position that requires lead support for multiple clinical projects using SAS. The ideal candidate will have a strong background in statistical programming and experience working with CDISC/TLF standards.

Key Responsibilities:
  • Provide lead statistical programming support for multiple clinical research study projects or study teams, ensuring timely delivery of high-quality results.
  • Develop statistical programming solutions using SAS (Base and Macros) and provide expert consultation to projects across the company including statistical programming methodology.
  • Ensure that 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.
  • Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-functional programming activities, and programming validation as needed.
  • Presents statistical programming topics internally and may present at external conferences.

Qualifications and Skills:

  • A bachelor's degree plus 4 years of experience in statistical programming 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.

Benefits and Challenges:

This role offers opportunities for professional growth and development, as well as collaboration with a team of experts in the field. However, it also requires strong problem-solving skills and attention to detail.

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