Immunome, Inc. · 1 day ago
Associate Director, Statistical Programming
Bothell, WA
Full-time
Onsite
Lead/Staff, Director/Executive
$193K/yr - $222K/yr
10+ years expImmunome, Inc. is a clinical-stage targeted oncology company dedicated to developing innovative cancer therapies. The Associate Director of Statistical Programming will oversee statistical programming activities for clinical studies, ensuring high-quality deliverables and compliance with regulatory standards.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
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
Qualification
Required
M.S. (or higher) in Statistics, Computer Science or other closely related field to programming with a minimum 10+ 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
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)
Preferred
Prior NDA submission and regulatory agency interaction experience highly desirable
Prior Oncology/Hematology experience highly desirable
Company
Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
51-200 employees
H1B Sponsorship
Immunome, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Leadership Team
Clay Siegall
President and CEO
Purnanand D. Sarma
President & CEO
Recent News
2026-01-09
BioWorld Financial Watch
2025-12-19
thefly.com
2025-12-18
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