
Data Analysis Specialist
2 weeks ago
The role of a Senior Statistical Programmer is to provide lead statistical programming support for multiple clinical projects using SAS. This involves 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 with SAS (Base and Macros) and provides expert consultation to projects across the company including statistical programming methodology.
- Ensures sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research involving CDISC standards and analysis data sets or production of standard and custom tables listings and figures.
- Delivers 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.
- 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 review, supports cross-functional programming activities, and programming validation as needed.
- Maintains awareness of current statistical programming techniques to ensure adoption of sound methodologies.
- Presents statistical programming topics internally and presents at external conferences.
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 in Clinical Research.
- Good analytical skills with 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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