Senior Manager, Statistical Programming
Immunome
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
Vacancy posted 5 days ago
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