
Statistical Data Analyst
1 week ago
The Senior Statistical Programmer provides lead statistical programming support for multiple clinical projects using SAS and delivers 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.
Key Responsibilities:
- Provides lead statistical programming support for multiple clinical research study projects or study teams.
- Develops statistical programming in 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.
- Delivers key outputs based on established proficiencies 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.
- Remains up-to-date with current statistical programming techniques to ensure the adoption of sound methodologies.
- Presents statistical programming topics internally and presents at external conferences.
Required Skills and Qualifications
A bachelor's degree plus 4 years of experience as a CDISC/TLF Statistical programmer in a Pharmaceutical/CRO environment is preferred. Education in a scientific discipline is advantageous.
Essential Qualifications:
- 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 beneficial.
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