Lead Data Analyst Position

2 days ago

Alleppey, Kerala, India beBeeStatistical Full time ₹ 12,00,000 - ₹ 19,20,000

**Statistical Programmer Role Overview**

The Senior Statistical Programmer provides lead statistical programming support for multiple clinical projects using SAS and serves as an expert consultant across the organization. Key responsibilities include delivering key regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff.

Key Responsibilities:

  • Leads statistical programming support for multiple clinical research study projects or study teams.
  • Provides statistical programming development with SAS (Base and Macros) and offers expert consultation to projects across the organization 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 deliverables based on established profiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.
  • Develops programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and may contribute to standardization efforts.
  • Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-functional programming activities, and programming validation as needed.
  • Stays current on current statistical programming techniques to ensure the adoption of sound methodologies.
  • Presents statistical programming topics internally and may present at external conferences.

**Qualifications**

  • A bachelor's degree plus 4 years Statistical programming experience as a CDISC/TLF Statistical programmer in 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.
  • Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.

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