Master's degree or higher in Statistics, Computer Science, or related field.
6+ years of relevant experience in the pharmaceutical/biotech industry.
Solid understanding of statistical programming principles and clinical trial processes.
Experience with NDA submissions and regulatory agency interactions is highly desirable.
Prior experience in Oncology/Hematology is a plus.
Responsibilities
Lead statistical programming for 1-2 clinical studies, ensuring quality deliverables throughout the study lifecycle.
Develop programming specifications based on the Statistical Analysis Plan and oversee CDISC-compliant dataset creation.
Provide hands-on SAS programming support for analyses and regulatory deliverables as needed.
Manage programming timelines, coordinate dependencies, and identify risks to align with study plans.
Collaborate with cross-functional teams to refine specifications and resolve data issues.
Review Data Management Plans and validation documentation to ensure data quality.
Oversee CRO programming activities and validate outputs for compliance and accuracy.
Benefits
Opportunity to mentor junior programmers and contractors.
Engagement in departmental initiatives and process improvements.
Collaborative work environment with cross-functional teams.
Focus on continuous improvement of statistical programming standards and tools.
Full Job Description
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.
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
Immunome is a biotechnology company that develops next-generation cancer immunotherapies. The company's proprietary discovery engine identifies novel cancer targets and develops antibody-based therapies to treat cancer. Immunome's lead product candidate, IMM-BCP-01, is a first-in-class cancer immunotherapy that targets a novel cancer antigen. The company is headquartered in Philadelphia, Pennsylvania.
