Senior Statistical Programming Lead - Oncology Trials

Immunome, Inc.; Bothell (WA); On-site; USD 176,000 - 201,000; Full time

Job summary

Immunome, Inc. in Washington state is seeking a Senior Manager, Statistical Programming to plan and execute SAS programming for clinical trial analyses, ensuring CDISC-compliant data packages ready for regulatory submission.

You will collaborate across Biostatistics, Data Management, Clinical Development and Safety, oversee CRO activities, and develop reusable macros to improve efficiency and scalability. This role offers leadership in setting standards and advancing oncology programs, with a

Qualifications

• Master’s degree in Statistics, Computer Science, or related field with minimum 6+ years of pharma/biotech experience.
• Solid knowledge of statistical programming principles and regulatory requirements.
• Prior NDA submission and regulatory agency interaction experience highly desirable.
• Prior Oncology/Hematology experience highly desirable.

Responsibilities

• Lead statistical programming activities for 1 or 2 assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle.
• Develop and/or view programming specifications based on the SAP and oversee 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 regulatory deliverables.
• Manage study programming timelines, coordinate dependencies, proactively identify risks, and ensure alignment with cross-functional study plans and milestones.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety to review requirements and resolve data or programming issues.
• Review Data Management Plans, case report forms, transfer specs, external/vendor data specifications, and validation docs for data quality and readiness.
• Oversee CRO statistical programming activities and ensure timely, high-quality delivery of datasets and analysis results.
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using Pinnacle 21 for CDISC compliance.
• Develop and maintain SAS macros, utilities, and programming standards for efficiency and consistency.
• Ensure adherence to CDISC standards, regulatory expectations, SOPs, and data traceability best practices.
• Mentor junior programmers or contractors supporting assigned studies.
• Contribute to cross-functional projects and departmental initiatives.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory knowledge

Mentoring

Education

Master’s degree in Statistics or related field

Tools

SAS

EDC systems

MS Excel

API data extracts

ETL

Job description

Immunome, Inc. in Washington state is seeking a Senior Manager, Statistical Programming to plan and execute SAS programming for clinical trial analyses, ensuring CDISC-compliant data packages ready for regulatory submission.

You will collaborate across Biostatistics, Data Management, Clinical Development and Safety, oversee CRO activities, and develop reusable macros to improve efficiency and scalability. This role offers leadership in setting standards and advancing oncology programs, with a