Clinical Data Analyst Specialist

8 hours ago

Madurai, Tamil Nadu, India beBeeStatistical Full time ₹ 10,00,000 - ₹ 15,00,000
Senior Statistical Programmer

The key objective of this position is to provide high-level statistical programming support for multiple clinical projects. The role involves delivering regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff.

Key Responsibilities:
  • Lead statistical programming support for multiple clinical research study projects or study teams.
  • Develop statistical programming with SAS (Base and Macros) and provide expert consultation to projects across the company including statistical programming methodology.
  • Evaluate sound methodologies 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.
  • Deliver key 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 contribute to standardization efforts.
  • Write well-documented, efficient, and high-quality code, conduct code review, support cross-functional programming activities, and programming validation as needed.
  • Maintain current knowledge of statistical programming techniques to ensure the adoption of sound methodologies.
Qualifications:
  • Bachelor's degree plus 4 years of experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment, education in scientific discipline preferred.
  • Understanding of GCP principles and other regulatory standards in Clinical Research.
  • Analytical skills with ability to process scientific and medical data.
  • Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.

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