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Principal Statistical Programmer - Everest Clinical Research
Software Engineer
Lead statistical programming for clinical trials, designing and delivering SAS/R solutions, ensuring CDISC compliance, and supporting regulatory submissions for pharmaceutical and biotech clients.
About the role
Key Responsibilities
- Design, develop, and validate SAS and R programs for data cleaning, analysis, and reporting across Phase I‑IV clinical studies.
- Lead implementation of CDISC standards (SDTM, ADaM) and ensure high‑quality deliverables for regulatory submissions.
- Collaborate with biostatisticians, data managers, and project teams to translate statistical analysis plans into executable code.
- Mentor junior programmers, review code, and enforce best practices and coding standards.
- Prepare and review FDA/EMA submission packages, including define.xml, analysis datasets, and tables, listings, and figures (TLFs).
Requirements
- 10+ years of statistical programming experience in the pharmaceutical or CRO environment.
- Advanced proficiency in SAS (Base, Macro, PROC REPORT, PROC SQL) and strong scripting skills in R or Python.
- Deep knowledge of CDISC SDTM/ADaM standards and regulatory submission requirements.
- Proven ability to lead projects, manage timelines, and communicate complex technical concepts to cross‑functional teams.
- Bachelor’s or higher degree in Statistics, Biostatistics, Computer Science, or related field.