Expert Statistical Analyst

1 day ago

Guntur, Andhra Pradesh, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 20,00,000

Job Summary:

The Senior Statistical Programmer plays a pivotal role in delivering regulatory-compliant output, developing programming documentation, and writing efficient code. This position requires a strong analytical mindset, expertise in statistical programming, and the ability to stay updated on emerging techniques.

About the Role:

  • Provide lead statistical programming support for multiple clinical projects using SAS.
  • Develop statistical programming with SAS (Base and Macros) and provide expert consultation to projects across the company.
  • Evaluate and implement sound methodologies 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.
  • Deliver 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, conducts code review, supports cross-functional programming activities, and programming validation as needed.
  • Stay current with emerging statistical programming techniques to ensure the 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.
  • Demonstrated understanding of GCP principles and other regulatory standards (e.g., FDA, EMA, and 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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