昆拓信诚医药研发(北京)有限公司

统计编程SAS Programmer（外派Biotech）

2 months ago

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该职位来源于猎聘

Lead Statistical Programming Activities
Oversee statistical programming for clinical studies or project-level tasks, including dataset generation (SDTM/ADaM) and TLF development/validation.
Develop and maintain programming plans aligned with SAP and data management workflows.
CRO Oversight & Deliverables Review
Monitor CRO programming progress and review deliverables (e.g., datasets, code) for CDISC compliance and accuracy.
Lead resolution of technical disputes (e.g., data mapping logic, derived variable definitions).
Tool & Standardization Development
Develop reusable macros, templates, and automation tools per company SOPs to enhance efficiency.
Contribute to SOP development/updates for statistical programming, ensuring compliance with relevant guidelines.
Cross-functional Collaboration
Collaborate with biostatisticians, data managers, and medical teams as a core project team member; report programming progress/risks.
Review eCRF design and optimize data structures for analytical requirements.
Data Quality & Compliance
Ensure timely delivery and validation of datasets/outputs for CSR, regulatory submissions, and ad-hoc analyses.
Lead programming-related QC activities to maintain audit readiness.