Senior Principal Statistical Programmer
RemoteUnited States
United StatesRemoteFull TimeSenior Level
Full TimeSenior Level
Job Summary
Lead statistical programming strategy and execution across oncology clinical development programs, driving CDISC strategy for SDTM, ADaM, and Define.xml. Oversee creation of submission-ready datasets, analyses, and programming deliverables for NDA, BLA, and MAA regulatory submissions. Serve as subject matter expert for complex analyses, integrated summaries, and inspection readiness while partnering cross-functionally to ensure operational excellence. Mentor programming teams, establish departmental standards, and provide strategic oversight of CRO activities and vendor deliverables.
Required Qualifications
- Legal authorization to work in the U.S.
- No visa sponsorship or transfer available
- 8+ years of statistical programming experience
- Pharmaceutical, biotechnology, or CRO industry experience
- 4+ years leading complex programming activities across multiple clinical programs
- Experience supporting NDA, BLA, MAA, or equivalent regulatory submissions
- Deep expertise in CDISC SDTM, ADaM, and Define.xml standards
- Advanced SAS programming expertise
- BS/MS in Computer Science, Statistics, Biostatistics, Mathematics, or related field
Desired Qualifications
- Experience with R
- Experience with modern analytics platforms
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