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
Join Our Experienced, Passionate Team
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.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
