Clinical SAS Programmer
Responsibilities:
- Support data management activities, systems, and processes across clinical studies supported by the Clinical Data Management team
- Conduct statistical programming work of clinical data using SAS software
- Ensure that all programs, outputs, and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs
- Generate analysis datasets according to CDISC standard and SAP
- Generate SDTM domains, ADaM datasets, and Define.xml files
- Run CDISC validation programs (e.g. OpenCDISC) reports to ensure ADaM datasets are CDISC compliant.
- Produce summary tables, graphs, and data listings using SAS
- Participate in TLF shell preparation and review and assist statistician for SAP preparation
- Develop standard SAS macros for efficient production of TLF
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
- Review output across programs to ensure consistency
- Validate programs and associated results produced by other programming colleagues
- Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timelines, and deliverables are met
- Oversee data transfers for assigned studies
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
- Participate in the development and/or maintenance of departmental procedures and standards
- Train and mentor new programmers
Requirements:
- Bachelor's degree or higher in a STEM field
- GCP Experience
- Minimum 5+ years of focused experience in clinical SAS programming
- Ability to work on multiple projects concurrently
- Ability to communicate verbally and in writing
- Maintain effective working relationships with a broad range of colleagues
- Desired Qualifications:
- Good understanding of clinical trial process and clinical technology
- Reviews trial protocols and assists in the planning and implementation of data Management processes
- Work cross-functionally with other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Ensure accurate development and execution of data integrations between databases such as EDC, LIMS, and other internal and external data sources
- Ensure data system compliance by following the established guidelines (e.g. FDA)