Senior Manager, Statistical Programming

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

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,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 ensure 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 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.
• 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.

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).