Senior Manager, Statistical Programming

Immunome, Inc.

6h • $175,545 - $200,965

About The Position

The Senior Manager, Statistical Programming plans, executes, and ensures the quality of SAS programming deliverables supporting clinical-trial analysis and reporting. The role ensures study data packages are submission-ready and compliant with CDISC standards, applicable regulatory guidance, and internal standards. It collaborates with Biostatistics, Data Management, Clinical Development, and other functions to develop and continually improve statistical programming standards, processes, tools, and infrastructure within the Biometrics department.

The role leads programming activities for one or two clinical studies across their full lifecycle, including development and review of specifications, hands-on programming when needed, oversight of CRO deliverables, and coordination of study timelines and dependencies. It also supports regulatory submissions, cross-functional data quality and programming readiness, and departmental initiatives. The position provides technical oversight and mentorship to junior programmers or contractors.

Requirements

• Master’s degree or higher in Statistics, Computer Science, or another closely related field to programming.
• At least 6 years of relevant pharmaceutical or biotechnology industry experience.
• Solid knowledge of statistical programming principles, clinical-trial processes, and regulatory requirements.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong technical skills in SAS, EDC systems, Microsoft Word, Excel, and PowerPoint, as well as API-based data extracts and ETL principles.
• Knowledge of industry standards including CDISC, SDTM, CDASH, and ADaM.
• Strong problem-solving and risk-mitigation skills.
• Excellent verbal, written, and interpersonal communication skills for effective cross-functional collaboration, including in person, by telephone, and by email.
• Dynamic self-starter who is an agile learner and strategic and creative thinker.

Nice To Haves

• Prior NDA submission and regulatory agency interaction experience.
• Prior Oncology/Hematology experience.

Responsibilities

• Lead statistical programming activities for one or two assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle.
• Develop and/or review programming specifications based on the Statistical Analysis Plan and oversee creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, tables, listings, figures (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 align work with cross-functional study plans and key milestones.
• Collaborate 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 and 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 assess CDISC compliance and support resolution of identified issues.
• Develop and maintain SAS macros, utilities, programming standards, and reusable tools to improve efficiency, consistency, and scalability across studies.
• Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and statistical programming and data traceability best practices.
• 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.

Benefits

• Medical, dental, and vision insurance coverage for employees and dependents, including 100% company-paid medical premiums for employees.
• 401(k) with employer match.
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D.
• Paid time off, company holidays, and a week-long winter break between Christmas and New Year’s.
• Paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior