Company Overview
Position 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. 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.
Qualifications
- 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.
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).
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).
Skills Required
- Master's degree or higher in Statistics, Computer Science, or a closely related programming field
- Minimum 4+ years of relevant pharmaceutical or biotechnology industry experience
- Solid knowledge of statistical programming principles, clinical trial processes, and regulatory requirements
- Strong working knowledge of SAS
- Knowledge of CDISC, SDTM, CDASH, and ADaM industry standards
- Knowledge of ICH, FDA, and GCP regulations and guidelines
- Experience with EDC systems, Microsoft Word, Excel, PowerPoint, API-based data extracts, and ETL principles
- Prior NDA submission and regulatory agency interaction experience
- Prior oncology or hematology experience
- Strong problem-solving, risk-mitigation, communication, and cross-functional collaboration skills
What We Do
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
