Senior Data Analyst

2 weeks ago

Ahmedabad, Gujarat, India beBeeStatistical Full time ₹ 20,00,000 - ₹ 25,00,000
Job Description

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

Responsibilities include:

  • Providing lead statistical programming support for multiple clinical research study projects or study teams.
  • Developing statistical programming solutions with SAS (Base and Macros) and offering expert consultation to projects across the company including statistical programming methodology.
  • Ensuring 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.
  • Delivering key results based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.
  • Developing programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and may contribute to standardization efforts.
  • Writing well-documented, efficient, and high-quality code, conducting code review, supporting cross-functional programming activities, and programming validation as needed.
  • Staying up-to-date with current statistical programming techniques to ensure the adoption of sound methodologies.
  • Presenting statistical programming topics internally and may present at external conferences.
Required Skills and Qualifications

Candidates must have 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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