Immunome, Inc.

Director

• 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.

Associate Director, Statistical Programming

• Lead and manage a high-performing team of MSLs, including recruitment, training, performance evaluation, and professional development
• Develop and execute the field medical strategy aligned with corporate objectives and medical affairs vision
• Guide the team in building and maintaining trusted scientific relationships
• Analysis and communication of MSL field insights to shape and refine corporate strategy
• Partner with medical affairs, clinical development, and commercial leadership to ensure scientific alignment and seamless cross-functional collaboration
• Ensure compliant coordination between medical and commercial teams
• Coordinate with clinical development teams on priorities and study support
• Develop and monitor key performance indicators and field metrics for scientific engagement effectiveness
• Ensure all field activities comply with corporate policies, applicable regulations, and ethical standards

Associate Director, Statistical Programming

Senior Director, Field Medical Affairs