Statistical Programming Manager

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.