onsite
Principal Statistical Programmer/Analyst Consultant Cardiovascular, Renal
Software Engineer
Lead advanced statistical programming and analysis for cardiovascular and renal clinical studies, driving data integrity and regulatory compliance using SAS, ADaM, and CDISC standards.
About the role
Key Responsibilities
- Design, develop, and validate SAS programs for ADaM datasets and statistical tables, ensuring adherence to CDISC standards.
- Collaborate with biostatisticians, data managers, and clinical teams to define analysis plans and resolve data quality issues.
- Perform complex data transformations, statistical analyses, and report generation for cardiovascular and renal therapeutic areas.
- Lead code reviews, maintain version control, and document programming logic for audit readiness.
- Mentor junior programmers and provide technical guidance on best practices.
Requirements
- 10+ years of experience in clinical data programming, with a focus on cardiovascular and renal studies.
- Expertise in SAS, ADaM, CDISC SDTM, and statistical analysis.
- Strong analytical skills and attention to detail in data validation and quality assurance.
- Excellent communication skills and ability to work cross-functionally.
- Experience with regulatory submissions and FDA/EMA guidelines.
Skills
software developmentsystem designproblem solving