Clinical Data Programmer

2 weeks ago

Bengaluru, India Unicon Pharma Inc Full time

**This is a Contract job for 3 months with possible extensions**

Primary Purpose

The Senior Statistical Programmer provides lead statistical programming support for multiple clinical projects using SAS and provides 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. The role also includes providing project updates to management while performing assigned duties and presents internally on statistical programming topics.


Responsibilities

  • Provides lead statistical programming support for multiple clinical research study projects or study teams.
  • Provides statistical programming development with SAS (Base and Macros) and provides expert consultation to projects across the company 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.
  • Provides 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.
  • Keep abreast of current statistical programming techniques to ensure the adoption of sound methodologies.
  • Presents statistical programming topics internally and may present at external conferences.
  • Provides project updates to appropriate project management or department management staff.


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 skills in prioritization, problem-solving, organization, decision-making, and time management.
  • Ability to articulate complex programming and technical concepts through written and oral communication.
  • Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.

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