Senior Manager, Statistical Programming

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 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,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.

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 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.
• Manage study programming timelines, coordinate dependencies, proactively identify risks, and ensu re 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.
• Oversee CRO statistical programming activities, review outputs for accuracy and compliance, and ensure timely , high‑quality delivery of datasets and analysis results.
• 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 .
• 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.
• Mentor and provide technical oversight to junior programmers or contractors supporting assigned studies.
• Contribute to and, where appropriate , lead departmental initiatives, process improvements, and cross‑functional projects beyond assigned study responsibilities.

Qualifications

• A m aster’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.
• Requires solid knowledge of statistical programming principles, clinical trials process and regulatory requirements.
• Prior NDA submission and regulatory agency interaction experience highly desirable.
• Prior Oncology/Hematology experience highly desirable.

Knowledge and Skills

• Dynamic self‑starter; agile learner; strategic and creative thinker.
• Demonstrated strong problem solving and risk‑mitigation skills.
• Excellent verbal/written and interpersonal skills 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.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• 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 ).

Washington State Pay Range

$175,545 - $200,965 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.