Principal Statistical Programmer

Immunome, Inc.; United States; Remote; USD 154,000 - 178,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) with match

Life insurance

Disability insurance

Paid time off

Parental leave

Job summary

Immunome, Inc. is seeking a Principal Statistical Programmer to act as a senior technical expert in the statistical programming space.

You will independently develop, validate, and deliver CDISC-compliant analyses and datasets, ensuring quality, traceability, and reproducibility of code and outputs. The role involves collaborating across Biostatistics, Data Management, and Clinical Operations, leading macros and reusable tools, and supporting NDA submissions with regulatory guidance.

Qualifications

• Master's degree in Statistics, Computer Science or related field with minimum 4+ years of pharma/biotech experience.
• Solid knowledge of statistical programming principles, clinical trial processes, and regulatory requirements.
• Prior NDA submission and regulatory agency interaction experience is highly desirable.
• Oncology/Hematology experience is highly desirable.

Responsibilities

• Develop and/or view programming specifications based on the SAP and oversee CDISC-compliant SDTM/ADaM datasets, TLFs, Define.xml, and reviewer guides.
• Provide hands-on SAS programming support for key analyses, data exploration, and regulatory deliverables.
• Adhere to study programming timelines, evaluate dependencies, identify risks, and align with cross-functional study plans and milestones.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements and resolve data issues.
• Review Data Management Plans, CRFs, data transfer specs, external/vendor data specs, and validation docs to ensure data quality.
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using Pinnacle 21 for CDISC compliance.
• Lead technical initiatives to develop SAS macros, utilities, and programming standards for efficiency and scalability.
• Ensure adherence to CDISC standards, regulatory expectations, SOPs, and best practices for programming and data traceability.
• Contribute to departmental initiatives, process improvements, and cross-functional projects.

Skills

SAS programming

CDISC SDTM/ADaM

Pinnacle 21

Regulatory knowledge

Cross-functional collaboration

ETL concepts

EDC systems

Education

Master's degree in Statistics or related field

Tools

SAS

EDC systems

MS Office

API data extracts

ETL

CDISC standards

Job description

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

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 ).

Washington State Pay Range

$154,230 - $177,726 USD

Working at Immunome gives you the opportunity to make a difference in the lives of cancer patients, contribute to developing best-in-class targeted cancer therapies, and work with some of the brightest and most experienced minds in antibody-drug conjugate (ADC) development.

Immunome's office is charged with the collective excitement and passion of people working together to develop life-changing cancer medicines. Our team thrives in an innovative, collaborative environment where employees are empowered to do their best work.

Immunome also offers a comprehensive benefit program for you and your family, including:

• Medical, dental, and vision insurance coverage for employees and their dependents, including 100% company-paid medical premiums for employees
• A 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 Years.
• Paid parental leave

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.