Senior Statistical Programmer: CDISC & SAS Expert

Immunomeinc; Bothell (WA); On-site; USD 154,000 - 178,000; Full time

Job summary

Immunome, Inc. in Washington state is seeking a Principal Statistical Programmer to serve as a senior technical expert. You will independently develop, validate, and deliver SAS programming deliverables for clinical trial analyses, ensuring accuracy and traceability.

You will lead cross-functional collaboration, support CDISC standards, and contribute to submission-ready data packages, with opportunities to shape programming standards and reusable tools.

Qualifications

• A master’s degree (or higher) in Statistics, Computer Science or other closely related field to programming with minimum 4+ years of relevant pharmaceutical/biotech industry experience.
• Requires solid knowledge of statistical programming principles, clinical trial process, and regulatory requirements.
• Prior NDA submission and regulatory agency interaction experience highly desirable.
• Prior Oncology/Hematology experience highly desirable.

Responsibilities

• Develop and/or view programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer guides.
• Provide hands-on SAS programming support for key analyses, data exploration, ad hoc requests, and internal or regulatory deliverables, as needed.
• Adhere to study programming timelines and evaluate dependencies, proactively identify risks, and ensure alignment with cross-functional study plans and key milestones.
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues.
• Review Data Management Plans, case report forms, data transfer specifications, external/vendor data specifications, and validation-related documentation to ensure data quality and downstream programming readiness.
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using industry-standard tools such as Pinnacle 21 to access CDISC compliance and support resolution of identified issues.
• Lead technical initiatives to develop and maintain SAS macros, utilities, and programming standards, and reusable tools to improve efficiency, consistency, and scalability across studies.
• Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability.
• Contribute to departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.
• May be required to lead statistical programming activities for assigned clinical studies working closely with Programming leadership.

Skills

SAS programming

CDISC SDTM/ADaM

Statistical programming

Regulatory knowledge

SAS macros

Education

Master’s degree in Statistics, Computer Science or related field

Tools

Pinnacle 21

EDC systems

MS Office

API data extracts

Job description

Immunome, Inc. in Washington state is seeking a Principal Statistical Programmer to serve as a senior technical expert. You will independently develop, validate, and deliver SAS programming deliverables for clinical trial analyses, ensuring accuracy and traceability.

You will lead cross-functional collaboration, support CDISC standards, and contribute to submission-ready data packages, with opportunities to shape programming standards and reusable tools.