Senior Manager, Statistical Programming

Immunome, Inc.; Washington (District of Columbia); On-site; USD 150,000 - 210,000; Full time

Job summary

Immunome, Inc. seeks a Senior Manager of Statistical Programming to lead SAS programming deliverables for clinical trials and ensure CDISC-compliant data packages and submission readiness.

The role directs 1–2 studies through their lifecycle, collaborating across biometrics functions to raise programming standards and infrastructure. In-depth experience with CDISC standards and FDA submission requirements is essential to drive regulatory-grade deliverables.

Qualifications

• Extensive SAS programming experience in clinical trials.
• Expertise with CDISC standards (SDTM, ADaM, Define.xml).
• Experience leading statistical programming teams or managing complex study deliverables.
• Strong knowledge of regulatory guidance and FDA submission requirements.
• Ability to collaborate across biostatistics, data management, and clinical teams.

Responsibilities

• Lead statistical programming for 1–2 assigned clinical studies throughout their lifecycle.
• Develop and review programming specifications aligned with Statistical Analysis Plans.
• Oversee creation, validation, and delivery of CDISC-compliant datasets and regulatory documentation.
• Provide hands-on SAS programming for analyses, ad hoc requests, and regulatory submissions.
• Collaborate on development and improvement of department programming standards and processes.

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

Lead programming teams

FDA submission knowledge

Cross-functional collaboration

Job description

Immunome seeks a Senior Manager of Statistical Programming to lead SAS programming deliverables for clinical trials, ensuring CDISC-compliant data packages and submission readiness. The role involves directing 1–2 studies through their lifecycle and collaborating across biometrics functions to enhance programming standards and infrastructure.

Responsibilities

• Lead statistical programming for 1–2 assigned clinical studies throughout their lifecycle
• Develop and review programming specifications aligned with Statistical Analysis Plans
• Oversee creation, validation, and delivery of CDISC-compliant datasets and regulatory documentation
• Provide hands-on SAS programming for analyses, ad hoc requests, and regulatory submissions
• Collaborate on development and improvement of department programming standards and processes

Requirements

• Extensive SAS programming experience in clinical trial environments
• Demonstrated expertise with CDISC standards (SDTM, ADaM, Define.xml)
• Experience leading statistical programming teams or managing complex study deliverables
• Strong knowledge of regulatory guidance and FDA submission requirements
• Cross-functional collaboration skills with biostatistics, data management, and clinical teams