Senior Manager, Statistical Programming

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](https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk) | [Right to Work Poster (English)](https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e) | [Right to Work Poster (Spanish)](https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u).