Leading Statistical Data Specialist

6 hours ago

Pune, Maharashtra, India beBeeStatistical Full time ₹ 23,04,000 - ₹ 2,59,20,000
Senior Statistical Programmer

Job Description

The Senior Statistical Programmer will lead statistical programming support for multiple clinical projects utilizing SAS and provide expert consultation across the organization. Primary responsibilities include delivering regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff.

Key Responsibilities

  • Provide 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 organization including statistical programming methodology.
  • Ensure sound methodologies are adopted by establishing proficiency of 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.
  • Deliver key deliverables based on established proficiency of 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 may 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 knowledge of current statistical programming techniques to ensure adoption of sound methodologies.
  • Present statistical programming topics internally and may present at external conferences.

Qualifications

  • A bachelor's degree plus 4 years of statistical programming 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.
  • Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.

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