Principal Statistical Programmer at Immunome, Inc. in Bothell, Washington, United States
- Company: Immunome, Inc.
- Location: Bothell, Washington, United States
- Posted: Sep 23, 2026
- Type: Full-time
- Salary: $154,230 - $177,726 USD
- Experience: 4+ years
Overview
As a Principal Statistical Programmer, you will serve as a senior technical expert within the individual contributor career track. You will independently develop, validate, document, and deliver high-quality SAS programming deliverables supporting the analysis and reporting of clinical trial results…
Job description
- As a Principal Statistical Programmer, you will serve as a senior technical expert within the individual contributor career track. You will independently develop, validate, document, and deliver high-quality SAS programming deliverables supporting the analysis and reporting of clinical trial results.
- The role will be accountable for the accuracy, quality, traceability, and reproducibility of its code and outputs. You will provide technical leadership on complex programming matters and serve as a technical resource to other programmers.
- This role will support the submission-readiness of study data packages by applying CDISC standards, applicable regulatory guidance, and internal standards.
- Working closely with Programming leadership, the role will contribute technical expertise to the continuous improvement of statistical programming standards, processes, tools, and infrastructure. This role may also collaborate cross-functionally with Biostatistics, Data Management, Clinical Development, and other functions.
Responsibilities
- 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.
- Adhere to study programming timelines and evaluate 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.
- 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.
- Lead technical initiatives to 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.
- Contribute to departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.
- May be required to lead statistical programming activities for assigned clinical studies working closely with Programming leadership.
Requirements
- A master’s degree (or higher) in Statistics, Computer Science or other closely related field to programming with minimum 4+ years of relevant pharmaceutical/biotech industry experience.
- Requires solid knowledge of statistical programming principles, clinical trial process, and regulatory requirements.
- Prior NDA submission and regulatory agency interaction experience highly desirable.
- Prior Oncology/Hematology experience highly desirable.
- 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).
Skills
Required
- SAS programming
- Statistical programming principles
- Clinical trial process knowledge
- Regulatory requirements knowledge
- CDISC standards (SDTM, ADaM, CDASH)
- EDC systems
- MS Word, Excel, PowerPoint
- API based data extracts
- ETL principles
Preferred
- Prior NDA submission experience
- Regulatory agency interaction experience
- Oncology/Hematology experience
Benefits
- $154,230 - $177,726 USD
About Immunome, Inc.
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.