
Lead Statistical Programming Specialist
3 days ago
The Senior Statistical Programmer provides lead statistical programming support for multiple clinical projects using SAS and delivers key regulatory-compliant output.
Key Responsibilities:- Delivers statistical programming development with SAS (Base and Macros) and expert consultation to projects across the company.
- 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.
For this role, we require a bachelor's degree plus 4 years' experience in statistical programming. You should have knowledge of GCP principles and other regulatory standards in Clinical Research, good analytical skills, and the ability to process scientific and medical data. Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software is beneficial.
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