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Bothell, Washington, United States
Posted · 24.09.2026
Greenhouse (US)

# Senior Manager, Statistical Programming

Immunome, Inc.

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview The Senior Manager,&nbsp;Statistical Programming will provide planning, execution, and quality of SAS programming deliverables supporting the analysis and reporting of clinical trial results. This role also ensures the submission-readiness of study data packages in accordance with CDISC standards, applicable regulatory guidance, and internal standards. This role will also collaborate cross-functionally with Biostatistics, Data Management, Clinical Development, and others to contribute to the development and continuous improvement of statistical programming standards, processes, tools and infrastructure within the Biometrics department.&nbsp;&nbsp; Responsibilities Lead statistical programming activities for 1 or 2 assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle.&nbsp; Develop and/or view programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and&nbsp;ADaM datasets, TLFs, Define.xml, and reviewer guides.&nbsp; Provide hands-on SAS programming support for key analyses, data exploration, ad hoc requests, and internal or regulatory deliverables, as needed. &nbsp; Manage study programming timelines, coordinate dependencies, proactively&nbsp;identify risks, and ensure alignment with cross-functional study plans and key milestones.&nbsp; Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues. &nbsp; 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. &nbsp; Oversee CRO statistical programming activities, review outputs for accuracy and compliance, and ensure&nbsp;timely, high-quality delivery of datasets and analysis results.&nbsp; 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.&nbsp;&nbsp; Develop and&nbsp;maintain SAS macros, utilities, and programming standards, and reusable tools to improve efficiency, consistency, and scalability across studies.&nbsp; Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability. &nbsp; Mentor and provide technical oversight to junior programmers or contractors supporting assigned studies. &nbsp; Contribute to and, where&nbsp;appropriate, lead departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.&nbsp;&nbsp; Qualifications A master’s degree (or higher) in Statistics, Computer Science or other closely related field to programming with minimum 6+ years of relevant pharmaceutical/biotech industry experience.&nbsp; Requires solid knowledge of statistical programming principles, clinical&nbsp;trials process and regulatory requirements.&nbsp; Prior NDA submission and regulatory agency interaction experience highly desirable. &nbsp; Prior Oncology/Hematology experience&nbsp;highly desirable.&nbsp;&nbsp; Knowledge and Skills Dynamic self-starter; agile learner; strategic and creative thinker.&nbsp; Demonstrated strong problem solving and risk-mitigation skills. &nbsp; Excellent verbal/written and interpersonal skills&nbsp;required to communicate and collaborate effectively with cross-functional teams (clinical operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email.&nbsp; Good working knowledge of ICH, FDA, and GCP regulations and guidelines. &nbsp; Strong, well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM).&nbsp;&nbsp; Washington State Pay Range$175,545&mdash;$200,965 USDE/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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