Principal Statistical Programmer

Role overview Serve as a senior individual contributor responsible for producing accurate, traceable, and reproducible statistical programming deliverables for clinical studies. The work covers hands-on analysis and reporting, oversight of submission-ready data packages, and technical guidance on programming standards and processes. The role works closely with programming leadership and partners across biostatistics, data management, clinical operations, and safety.

Responsibilities - Translate statistical analysis plans into programming specifications and develop or oversee CDISC-compliant SDTM and ADaM datasets, tables, listings, figures, Define.xml files, and reviewer guides. - Write SAS programs for analyses, data exploration, ad hoc requests, and internal or regulatory deliverables. - Track study milestones and dependencies, identify risks early, and coordinate programming work with cross-functional study plans. - Review data management plans, case report forms, transfer specifications, vendor data specifications, and validation documents for downstream readiness. - Validate outsourced datasets, outputs, and submission components, assess standards compliance, and help resolve findings. - Build and maintain SAS macros, reusable tools, and programming standards to improve consistency and efficiency; contribute to process improvements and may lead programming for assigned studies.

Requirements - Master’s degree or higher in statistics, computer science, or a closely related programming field, with at least four years of relevant pharmaceutical or biotechnology experience. - Sound understanding of statistical programming, clinical trial processes, and regulatory requirements. - Strong SAS skills and working knowledge of EDC systems, data extracts, ETL principles, and tools such as Word, Excel, and PowerPoint. - Knowledge of CDISC standards, including SDTM, CDASH, and ADaM, and of ICH, FDA, and GCP guidance. - Clear written and verbal communication, effective cross-functional collaboration, and strong problem-solving and risk-management skills.

Nice to have - Experience with NDA submissions and interactions with regulatory agencies. - Oncology or hematology experience.

Benefits and work setup The listed Washington State base pay range is $154,230–$177,726. Benefits include medical, dental, and vision coverage, employer matching contributions to a 401(k), life and disability insurance, paid time off and holidays, a winter break, and paid parental leave.