Senior SAS Programming Lead for CDISC Clinical Trials

Immunome, Inc.; Washington (District of Columbia); Presencial; USD 150 000 - 210 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

SAS programming

CDISC SDTM/ADaM/Define.xml

Lead programming teams

FDA submission knowledge

Cross-functional collaboration

Descrição da oferta de emprego

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.