
Highly Skilled Statistical Programmer Wanted
1 week ago
Key Responsibilities
- Lead programming support for multiple clinical research projects or teams.
- Develop high-quality statistical programming code in SAS and provide consultation on methodology.
- Ensure sound methodologies are adopted by establishing proficiency in programming techniques required for clinical trials research involving CDISC standards, analysis data sets, and production of standard and custom tables, listings, and figures.
- Deliver key regulatory-compliant output, including E-submissions and/or study requirements for Sponsor, Regulatory, Investigator, or Safety review meetings.
- Develop comprehensive programming documentation and annotations, adhering to relevant Standard Operating Procedures and contributing to standardization efforts.
- Write well-documented, efficient, and high-quality code, conduct code reviews, support cross-functional programming activities, and perform programming validation as needed.
- Remain current with emerging statistical programming techniques to ensure the adoption of sound methodologies.
- Present statistical programming topics internally and may present 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, with a scientific discipline preferred.
- Demonstrated understanding of GCP principles and other regulatory standards in Clinical Research, including FDA, EMA, and ICH guidance and recommendations.
- Strong analytical skills with the ability to process complex scientific and medical data.
- Expertise in SAS, with familiarity with R, Python, or other relevant statistical software beneficial.
Why This Role Matters
This role plays a key part in advancing our statistical capabilities and ensuring compliance with regulatory requirements. The successful candidate will be able to work effectively in a team environment and remain up-to-date with emerging statistical programming techniques.
Benefits and Opportunities
The ideal candidate will have excellent communication skills and be able to present complex ideas effectively. Opportunities for professional development and growth will be available to the right candidate.
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