Statistical Programmer Consultant
Job Summary
To support clinical trial initiatives, the full-time Statistical Programmer Consultant will independently lead statistical programming activities, generate datasets, and provide technical support for regulatory submissions in a remote setting, preferably aligned with West coast hours.
Key responsibilities
- Act as the lead programmer for assigned clinical trials, collaborating with study teams to provide statistical programming support
- Design, create, and validate SDTM and ADaM datasets, ensuring data traceability and quality
- Perform statistical analysis and generate Tables, Listings, and Figures (TLFs) using SAS for Clinical Study Reports and regulatory submissions
Required qualifications
- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific discipline
- 8+ years of statistical programming experience in a bio/pharma company or clinical research organization (CRO)
- Advanced proficiency in SAS, including data steps, Macro language, and common analysis procedures
- Comprehensive understanding of CDISC standards and experience with regulatory package artifacts
- Demonstrated ability to work independently and manage multiple high-priority projects in a fast-paced environment
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