Spec 3, Statistics & Statistics Programming

We are seeking a Senior Statistical Programmer Contractor to provide hands-on programming support for clinical studies, developing and validating analysis datasets and statistical outputs in line with regulatory and internal standards. This is an individual contributor role requiring a high level of independence, strong technical expertise, and effective collaboration with Biostatistics and Clinical Data Management. The position is based in Irvine, California, with an expectation of onsite presence approximately 3-4 days per week.

Key responsibilities include developing complex analysis datasets, specifications, and summary outputs such as tables, listings, figures, and graphs for clinical study reports, regulatory submissions, and internal presentations. You will create, maintain, and enhance SAS programs to support efficient reporting, review, and traceability, while ensuring all deliverables are accurate, well documented, and inspection ready. The role also involves supporting planned and ad hoc analyses, responding to data review questions, and partnering with cross-functional teams to review CRFs, database specifications, edit checks, and data derivations. You will be expected to identify programming risks, data issues, and process improvement opportunities proactively.

To be successful, you should hold a bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field with 8+ years of relevant experience, or a master’s degree with 6+ years of experience. Strong SAS programming expertise is essential, including SAS Base, SAS/STAT, and SAS Macros, along with experience in clinical trials and CDISC standards such as SDTM and ADaM. A solid understanding of GCP, ICH, FDA, and ISO requirements is required. Experience with regulatory submissions, CRO/vendor validation, SAS macro development, or additional languages such as R or Python would be advantageous.

Must-Have Skills: SAS, SAS Base, STAT, SAS Macros, CDISC, ADaM, SDTM, clinical trials

Nice-to-Have Skills: GCP, ICH, FDA, ISO, Microsoft Excel, Microsoft Word, PowerPoint, regulatory submissions, CRO validation, R, Python