Senior Statistical Programmer — Oncology Trials & CDISC Lead

Immunome, Inc.; Bothell (WA); On-site; USD 154,000 - 178,000; Full time

Job summary

Immunome, Inc. is seeking a Principal Statistical Programmer to be a senior technical expert within the individual contributor track.

You will independently develop, validate, and deliver SAS programming deliverables for clinical trial analysis and reporting, ensuring accuracy, traceability, and reproducibility of code. The role provides technical leadership on complex programming matters, supports CDISC standards, and collaborates with Biostatistics, Data Management, Clinical Development, and

Qualifications

• Master's degree (or higher) in Statistics, Computer Science or related field
• Minimum 4+ years of relevant pharma/biotech industry experience
• Solid knowledge of statistical programming principles and regulatory requirements
• Prior NDA submission and regulatory agency interaction experience desirable
• Oncology/Hematology experience desirable

Responsibilities

• Develop and oversee CDISC-compliant SDTM/ADaM datasets, TLFs, Define.xml, and reviewer guides
• Provide hands-on SAS programming support for analyses and regulatory deliverables
• Adhere to study programming timelines and evaluate dependencies, identify risks
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety teams
• Review Data Management Plans, CRFs, data transfer specifications, and validation docs
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using Pinnacle 21
• Lead initiatives to develop SAS macros, utilities, and reusable tools
• Ensure adherence to CDISC standards, SOPs, and data traceability
• Contribute to departmental initiatives and cross-functional projects
• May lead statistical programming activities for assigned studies

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory knowledge

GCP familiarity

Cross-functional work

Data management liaison

Statistical programming principles

API data extracts

Education

Master's degree in Statistics or related field

Tools

Pinnacle 21

EDC systems

MS Excel

Job description

Immunome, Inc. is seeking a Principal Statistical Programmer to be a senior technical expert within the individual contributor track.

You will independently develop, validate, and deliver SAS programming deliverables for clinical trial analysis and reporting, ensuring accuracy, traceability, and reproducibility of code. The role provides technical leadership on complex programming matters, supports CDISC standards, and collaborates with Biostatistics, Data Management, Clinical Development, and