Principal Statistical Programmer
Immunome
Immunome seeks a Principal Statistical Programmer to lead SAS programming efforts for clinical trial data analysis and regulatory submissions. This senior individual contributor role involves developing CDISC-compliant datasets, analysis outputs, and documentation while providing technical guidance to programming teams.
Responsibilities
- Develop programming specifications and oversee creation of CDISC-compliant SDTM and ADaM datasets
- Create and validate tables, listings, figures, and regulatory reviewer documentation
- Provide hands-on SAS programming support for analyses, data exploration, and ad hoc requests
- Serve as technical resource and mentor to other statistical programmers on complex matters
- Contribute to improving programming standards, processes, and infrastructure
Requirements
- Extensive SAS programming experience with clinical trial data
- Proficiency in CDISC standards (SDTM, ADaM) and regulatory compliance
- Demonstrated expertise in statistical programming specifications and validation
- Strong knowledge of clinical data management and analysis processes
- Experience with Define.xml and regulatory submission documentation
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