remote
Senior Statistical Programmer - Everest Clinical Research
Software Engineer
Senior Statistical Programmer leading the design, development, and validation of clinical trial datasets and statistical programs using SAS, R, and Python, ensuring CDISC compliance and supporting regulatory submissions.
About the role
Key Responsibilities
- Design, develop, and validate SAS programs to create SDTM and ADaM datasets for Phase I‑IV clinical trials.
- Collaborate with biostatisticians, data managers, and clinical teams to translate analysis plans into executable code.
- Implement and maintain CDISC standards, ensuring data quality and regulatory compliance.
- Perform statistical analyses, generate tables, listings, and figures (TLFs) for study reports and submissions.
- Mentor junior programmers, review code, and provide technical guidance on best practices.
Requirements
- 5+ years of experience in statistical programming within the pharmaceutical or CRO environment.
- Advanced proficiency in SAS (Base, Macro, PROC SQL) and strong knowledge of R or Python for data manipulation and analysis.
- Hands‑on experience with CDISC standards, including SDTM and ADaM dataset creation.
- Familiarity with regulatory submission requirements (FDA, EMA) and ability to produce submission‑ready deliverables.
- Excellent problem‑solving, communication, and teamwork skills.