Principal Programmer, Statistical Programming
$154,155–$195,000 year
On-site · San Diego, California, United States
Job Summary
Principal Programmer, Statistical Programming leads programming activities for multiple oncology clinical studies, developing and validating SAS programs to analyze and report trial data, managing SDTM/ADaM datasets and define.xml, performing conformance checks with Pinnacle 21, and ensuring regulatory submission readiness. The role involves creating programming plans, overseeing CRO deliverables, developing global macros to improve efficiency, and contributing to standards and SOPs, with onsite work based in San Diego.
Required Qualifications
- Minimum BS in Statistics, Computer Science, Life Sciences or related fields
- BS with 7+ years or MS with 5+ years of SAS programming experience in drug development in CRO or pharma/biotech
- Experience with data reporting tools in a clinical trial setting
- Expert level SAS programming skills; knowledge of R, Python, PL/SQL a plus
- Good knowledge of clinical trial design, data collection/cleaning, regulatory requirements and their relationship with data analysis
- Familiar with ICH guidelines, advanced knowledge of submission requirements and standards
- Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM
- Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests
- Excellent verbal and written communication skills
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