Experienced Statistical Programming Lead

2 days ago

Hubli, Karnataka, India beBeeStatistical Full time ₹ 12,00,000 - ₹ 15,00,000
Job Title:

Senior Statistical Programmer

Job Description:

We are seeking an experienced Senior Statistical Programmer to lead statistical programming support for multiple clinical projects. This role involves delivering regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff.

The successful candidate will have a strong background in statistical programming with expertise in SAS. They will provide expert consultation to projects across the company and ensure sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research involving CDISC standards and analysis data sets or production of standard and custom tables listings and figures.

Key responsibilities include providing lead statistical programming support for multiple clinical research study projects or study teams, ensuring regulatory requirements for clinical research submissions and/or study requirements for Sponsor, Regulatory, Investigator, or Safety review meetings.

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

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