Principal Statistical Programmer

Immunome, Inc.

1d • $154,230 - $177,726

About The Position

The Principal Statistical Programmer serves as a senior technical expert on the individual-contributor career track. The role independently develops, validates, documents, and delivers high-quality SAS programming deliverables supporting the analysis and reporting of clinical trial results, with accountability for the accuracy, quality, traceability, and reproducibility of code and outputs.

The position provides technical leadership on complex programming matters and acts as a technical resource to other programmers. It supports submission readiness by applying CDISC standards, applicable regulatory guidance, and internal standards. In collaboration with Programming leadership, the role contributes technical expertise to improvements in statistical programming standards, processes, tools, and infrastructure. It may also work cross-functionally with Biostatistics, Data Management, Clinical Development, and other functions.

Requirements

• Master’s degree or higher in Statistics, Computer Science, or another closely related programming field.
• At least 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 ICH, FDA, and GCP regulations and guidelines.
• Strong technical skills in SAS, EDC systems, Microsoft Word, Excel, PowerPoint, 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.

Nice To Haves

• Prior NDA submission and regulatory agency interaction experience.
• Prior Oncology/Hematology experience.
• Dynamic self-starter, agile learner, strategic thinker, and creative thinker.

Responsibilities

• 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.
• Adhere to study programming timelines, evaluate 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 specifications, external/vendor data specifications, and validation-related documentation to support 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 assess CDISC compliance and support resolution of identified issues.
• Lead technical initiatives to develop and maintain SAS macros, utilities, programming standards, and reusable tools that 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 lead statistical programming activities for assigned clinical studies in collaboration with Programming leadership.

Benefits

• Medical, dental, and vision insurance 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 and company holidays.
• A week-long winter break between Christmas and New Year’s.
• Paid parental leave.

What This Job Offers

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