Clinical Trials Data Analyst Lead

1 day ago

Lucknow, Uttar Pradesh, India beBeeStatistical Full time ₹ 7,00,000 - ₹ 11,00,000
Job Description

The Senior Statistical Programmer is responsible for providing lead statistical programming support for multiple clinical projects using SAS. The individual will provide expert consultation across the company.

Key Responsibilities:

  • Provides statistical programming support for multiple clinical research study projects or study teams.
  • Develops and implements statistical programming with SAS (Base and Macros) and provides expert consultation to projects across the company including statistical programming methodology.
  • Ensures 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.
  • Delivers key regulatory-compliant output based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.
  • Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-functional programming activities, and programming validation as needed.
  • Keeps abreast of current statistical programming techniques to ensure the adoption of sound methodologies.

Required Skills and Qualifications:

  • A bachelor's degree plus 4 years of experience as a CDISC/TLF Statistical programmer in a 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.

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