Overview
The Senior Statistical Programmer/Analyst Consultant role focuses on delivering key programming components for clinical studies within the Respiratory and Immunology (R&I) domain. The consultant will work closely with a single sponsor while benefiting from the support of a global CRO, establishing a collaborative environment with client counterparts. This position demands a high level of technical expertise in programming and an understanding of industry standards for clinical trials.
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 support submission activities.
Requirements
- Bachelor’s degree in computer science, statistics, or related scientific disciplines with 5 years of clinical programming experience; or a Master’s degree with 6 years of relevant experience.
- Strong SAS programming experience within the pharmaceutical/CRO industry.
- Hands-on experience supporting Respiratory and Immunology studies.
- Experience generating and validating SDTM, ADaM, and TLFs.
- Good understanding of CDISC standards and clinical trial processes.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Experience supporting regulatory submissions is preferred.
- Strong communication and stakeholder management skills.