Senior Oncology Statistical Programming Lead

Immunomeinc; Bothell (WA); On-site; USD 176,000 - 201,000; Full time

Job summary

Immunome, Inc. in Bothell, WA is seeking a Senior Manager, Statistical Programming to lead programming activities for clinical studies and ensure CDISC-compliant data deliverables. You will collaborate across Biostatistics, Data Management, Clinical Development, and Safety to advance trial analyses and submission readiness.

The role emphasizes mentoring junior programmers, developing SAS macros and standards, and guiding CRO work to meet regulatory expectations.

Qualifications

• Master’s degree (or higher) in Statistics, Computer Science or related field with 6+ years of pharma/biotech experience.
• Solid knowledge of statistical programming principles, clinical trials process and regulatory requirements.
• NDA submission and regulatory agency interaction experience is highly desirable.
• Oncology/Hematology experience is 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 oversee CDISC SDTM/ADaM datasets, TLFs, Define.xml, and reviewer guides based on the SAP.
• Provide SAS programming support for analyses, data exploration, and regulatory deliverables.
• Manage study programming timelines and cross-functional dependencies, identifying risks and aligning with milestones.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety to refine specs and resolve issues.
• Review Data Management Plans and data specifications to ensure data quality and downstream readiness.
• Oversee CRO statistical programming activities and ensure timely delivery of datasets and analyses.
• Validate CRO outputs using Pinnacle 21 for CDISC compliance and issue resolution.
• Develop SAS macros, utilities and standards to improve efficiency and reuse across studies.
• Ensure adherence to CDISC standards, regulatory expectations, SOPs and traceability.
• Mentor junior programmers and contractors supporting studies.
• Contribute to departmental initiatives and cross-functional projects.

Skills

Statistical programming

Regulatory knowledge

Collaboration

Education

Master's degree in Statistics or related

Tools

SAS

EDC systems

Excel

PowerPoint

API data extracts

ETL principles

Pinnacle 21

Job description

Immunome, Inc. in Bothell, WA is seeking a Senior Manager, Statistical Programming to lead programming activities for clinical studies and ensure CDISC-compliant data deliverables. You will collaborate across Biostatistics, Data Management, Clinical Development, and Safety to advance trial analyses and submission readiness.

The role emphasizes mentoring junior programmers, developing SAS macros and standards, and guiding CRO work to meet regulatory expectations.