1388# Principal Statistical Programmer Consultant Remote (Oncology)
Skills
- Strong SAS programming (BASE, STAT, Macros) proficiency
- CDISC standards expertise (SDTM and ADaM)
- Experience creating define.xml, annotated CRFs, and ADaM/SDTM specifications
- Ability to develop and validate macros and automated output pipelines
- Familiarity with regulatory and industry standards (FDA guidance)
- Experience overseeing outsourced CRO work and delivering quality-controlled outputs
- Excellent communication and stakeholder-management skills
Responsibilities
- Provide oversight of dataset development (SDTM/ADaM) by CROs and ensure CDISC compliance with clear specifications, trackers, and checklists
- Generate and/or review SDTM mapping specs, annotated CRFs, ADaM specs, define.xml, and reviewer’s guides per CDISC/FDA guidance
- Accountable for oversight of statistical programming deliverables for in-house and outsourced projects
- Independently develop and validate SAS programs, macros, and specifications for outputs including publications, safety reporting, and ad hoc analyses
- Provide technical leadership and problem-solving for moderate to high complexity programming tasks within project timelines
- Oversee and mentor junior programmers and manage outsourced programming partners
- Develop/validate standard macros to automate output production and ensure reproducibility
- Adhere to company SOPs and department guidelines and contribute to department infrastructure development
- Work concurrently on multiple projects and troubleshoot technical and project issues
- Communicate effectively with internal cross-functional teams and external partners
Education
- BS/BA degree in a related discipline (required)
Benefits
- Professional development and continuous training
- Access to global CRO career opportunities and cross-functional experience
- Supportive company culture with low turnover
- Remote work flexibility
- Exposure to high-quality, regulated clinical projects and mentoring opportunities
Average salary estimate
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