Immunome, Inc.

Associate Director, Statistical Programming

Immunome, Inc.

full-time

Posted on:

Location Type: Remote

Location: Washington • United States

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Salary

💰 $193,155 - $222,021 per year

Job Level

Senior

About the role

  • Lead all statistical programming activities for 1 or 2 assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle.
  • Develop 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’s guides.
  • Provide hands-on SAS programming support for key analyses, data exploration, and internal or regulatory deliverables as needed.
  • Manage study programming timelines, coordinate dependencies, and ensure alignment with cross-functional study plans and 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, and validation plans to ensure 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 tools (e.g., Pinnacle 21) and resolve compliance issues.
  • Develop and maintain SAS macros, utilities, and programming tools that improve efficiency, consistency, and scalability across study deliverables.
  • 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 departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.

Requirements

  • Master's degree (or higher) in Statistics, Computer Science or other closely related field to programming with a minimum 8+ 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingCDISC standardsSDTM datasetsADaM datasetsTLFsDefine.xmlstatistical programming principlesprogramming specificationsSAS macrosdata validation
Soft Skills
leadershipcollaborationmentoringproblem-solvingcommunicationorganizational skillsattention to detailproject managementcross-functional coordinationprocess improvement