Advanced Data Analyst and Statistician

12 hours ago

Anand, Gujarat, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 20,00,000

Senior Statistical Programmer Role Overview

The primary purpose of this position is to provide lead statistical programming support for multiple clinical projects using SAS, serving as a key expert in statistical methodology across the organization.

  • Provide advanced statistical programming support for various clinical research study projects or study teams, utilizing expertise in programming methodologies and techniques.
  • Develop sophisticated statistical programming with SAS (Base and Macros) and offer consultation services to projects within the company, ensuring alignment with industry standards and regulatory requirements.
  • Evaluate and ensure sound methodologies are adopted by establishing proficiency in programming techniques required for clinical trials research, focusing on CDISC standards and analysis data sets or production of standard and custom tables, listings, and figures.
  • Deliver critical project outcomes based on established proficiency in regulatory requirements for clinical research e-submissions and/or study requirements for Sponsor, Regulatory, Investigator, or Safety review meetings.
  • Develop comprehensive programming documentation and annotations, including specifications, review of mock shells, adherence to relevant Standard Operating Procedures, and contributions to standardization efforts.
  • Write well-documented, efficient, and high-quality code, conduct code reviews, support cross-functional programming activities, and programming validation as needed.
  • Remain up-to-date on current statistical programming techniques to ensure adoption of sound methodologies and best practices.
  • Present statistical programming topics internally and may present at external conferences to share knowledge and expertise.

Requirements and Qualifications

  • A bachelor's degree plus 4 years of experience in statistical programming as a CDISC/TLF statistical programmer in a Pharmaceutical/CRO environment, with a scientific discipline background 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 effectively.
  • Strong statistical programming skills in SAS, familiarity with R, Python, or other relevant statistical software considered beneficial.

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