Lead Statistical Programmer – Oncology, CDISC SDTM/ADaM Expert

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, 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.