Senior Statistical Programmer
Not Disclosed•ContractorOn-site
location_onLeafy Pass, Groves, Orchard Hills, Irvine, Orange County, California, 92602, United States
About the Role
We are seeking a Senior Statistical Programmer to provide hands-on statistical programming support for clinical studies. In this contract role, you will be responsible for the development and validation of analysis datasets and statistical outputs, ensuring strict adherence to regulatory and company standards. This position is designed for an independent contributor who can deliver high-quality programming deliverables while collaborating effectively with Biostatistics and Clinical Data Management teams.
You will work independently with minimal supervision, receiving high-level objectives and delivering agreed-upon outputs. Your work will directly support the creation of complex analysis datasets, specifications, and summary outputs (tables, listings, figures, and graphs) for inclusion in clinical study reports and regulatory submissions. As a key member of the study team, you will partner with cross-functional stakeholders to review CRFs, database specifications, and edit checks, while proactively identifying programming risks and efficiency opportunities.
Hiring Process
This is a contract position running from June 8 to December 31, 2026, based in Irvine, CA. The schedule is 1st Shift, 9:00 AM - 5:00 PM. Candidates will be evaluated on their ability to work independently, manage assigned programming tasks and timelines, and apply sound judgment in accordance with regulatory and quality standards.
Equal Opportunity
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Work location
Work model: On-site
Leafy Pass, Groves, Orchard Hills, Irvine, Orange County, California, 92602, United States
Irvine, California
Key Responsibilities
- check_circleDevelop complex analysis datasets, specifications, and summary outputs for clinical study reports
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Skills, education and keywords
Skills: Base Sas, Cdisc Standards, Sas Macros, Sas/stat, Python, R, Sas Programming, SDTM, Adam, GCP.
Education: Bachelor's degree in Statistics, Mathematics, Computer Science, or related field with 5+ years experience; Master's degree in a related field with 3+ years experience.
Frequently asked questions about Senior Statistical Programmer at City of Irvine
What does a Senior Statistical Programmer at City of Irvine do?expand_more
Day-to-day, the Senior Statistical Programmer at City of Irvine will develop complex analysis datasets, specifications, and summary outputs for clinical study reports; support ad hoc and planned analyses in collaboration with designated statisticians; partner with clinical data management to review crfs, database specifications, and edit checks; and proactively identify programming risks, data issues, or efficiency opportunities.
What are the requirements for this Senior Statistical Programmer role?expand_more
City of Irvine is looking for candidates who meet the following requirements: Bachelors degree in Statistics, Mathematics, Computer Science, or related field with 5+ years experience OR Masters degree with 3+ years experience; Experience in clinical trials environment (pharmaceutical/medical device); Strong hands-on SAS programming (SAS Base, SAS/STAT, SAS Macros); Experience developing and validating analysis datasets, tables, listings, and figures; Solid understanding of regulatory requirements (GCP, ICH, FDA, ISO); and Experience with CDISC standards (SDTM, ADaM).