Senior Manager, Statistical Programming

Immunome · Bothell, WA

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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