Advanced Statistical Programming Specialist

2 days ago

Salem, Tamil Nadu, India beBeeDataScientist Full time ₹ 11,04,000 - ₹ 15,32,000
Lead Statistical Programmer Role

Primary Responsibility:

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:

  • Provides lead statistical programming support for multiple clinical research study projects or study teams.
  • Develops statistical programming using SAS (Base and Macros) and provides expert consultation to projects across the organization, including statistical programming methodology.
  • Ensures that sound methodologies are adopted by establishing proficiency in programming techniques required for clinical trials research, involving either CDISC standards and analysis data sets or production of standard and custom tables, listings, and figures.
  • Delivers key outputs based on established proficiency in 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 contributes to standardization efforts.
  • Writes well-documented, efficient, and high-quality code, conducts code reviews, supports cross-functional programming activities, and programming validation as needed.
  • Remains up-to-date with current statistical programming techniques to ensure the adoption of sound methodologies.
  • Presents statistical programming topics internally and may present at external conferences.

Qualifications and Skills:

  • 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 is 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 is considered beneficial.

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