Senior Statistical Programmer

Job Summary

Leading the development and validation of high-quality CDISC datasets, the full-time remote Senior Statistical Programmer will design program specifications, create eSubmission deliverables, and provide mentorship while collaborating with internal and external teams.

Key responsibilities

• Lead discussions with clients on database design using expertise in data standards and regulatory requirements
• Independently author SDTM specifications from scratch and utilize tools for data conformance and submissions
• Mentor and train peers and junior programmers in statistical programming and CDISC standards

Required qualifications

• BA/BS in computer science, statistics, or a related field with at least 6 years of statistical programming experience in the SAS language
• Extensive experience with the SDTM model and CDISC standards, including end-to-end submissions
• Proficiency in SAS/Base programming, with skills in modifying and writing SAS code
• Knowledge of clinical trials and applicable regulatory requirements, including GCP and ICH guidelines
• Experience with data submission conformance tools and creation of define.xml files