Contractor – Principal Statistical Programmer

The Principal Statistical Programmer will provide expert-level hands-on programming support and technical expertise to develop, maintain, validate, and execute SAS programs that access, visualize, analyze, and report clinical trial data in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. Supports statistical programming for in-house and outsourced clinical trials, commercial requests, HEOR analyses, pooled analyses (ISE/ISS), biomarker analyses, and ad hoc analyses.

• Support study leads and take ownership of multiple deliverables across drug programs and platforms.
• Act as an integral project team member, collaborating with vendors, biostatisticians, data managers, and cross-functional teams.
• Primary role for production of tables, listings, and figures, and CRF tabulations (including ISS/ISE).
• Serve as primary programmer for regulatory, commercial, ad hoc, biomarker, and HEOR analyses.
• Review critical Standards Artifacts and Processes (e.g., SAPs, Data Validation Plans, eCRFs) and provide comments.
• Troubleshoot and provide quality review of complex SAS programs; follow good programming practices and document programs.
• Understand and follow FDA regulations affecting clinical trial data reporting.

• At least 8 years relevant experience (5+ years may be considered);
  Bachelor’s degree.
• Oncology experience required; leukemia experience preferred.
• Excellent communication to non-technical colleagues; completed large/complex projects; handle multiple projects with aggressive timelines.
• Advanced/excellent SAS knowledge; familiarity with coding dictionaries (WHO, MedDRA); expert in CDISC.
• Knowledge of medical/statistical terminology; capable with Windows, Word, and Excel.