Overview
The Principal Statistical Programmer/Analyst Consultant will join a client-focused Cardiovascular, Renal & Metabolism (CVRM) team under the leadership of a Programming team leader. This role involves managing technical programming tasks, providing statistical programming expertise, and ensuring the delivery of high-quality programming work within project timelines. The consultant will have the opportunity to work independently while maintaining strong communication with stakeholders.
Responsibilities
- Develop, validate, and maintain SAS programs for clinical study data analysis and reporting.
- Create datasets, tables, listings, and figures according to study requirements.
- Collaborate with Biostatistics, Data Management, and Clinical teams.
- Ensure programming deliverables meet quality standards and project timelines.
- Participate in study planning and review specifications.
- Support submission activities.
Requirements
- Bachelor’s degree in computer science, statistics, or related scientific disciplines with 5 years of clinical programming experience; Master’s degree with 6 years of experience.
- Strong SAS programming experience within the pharmaceutical/CRO industry.
- Hands-on experience supporting CVRM studies.
- Experience in generating and validating SDTM, ADaM, and TLFs.
- Good understanding of CDISC standards and clinical trial processes.
- Experience supporting regulatory submissions is preferred.
- Working knowledge of ICH and Good Clinical Practices.