Senior Manager, Statistical Programming
Full Job Posting
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 ensu re 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 m aster’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).
About Immunome, Inc.
Public clinical-stage biotechnology company developing targeted oncology therapies for cancer patients.
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