Software Engineer

• Develop and review SDTM and ADaM dataset specifications, annotated CRFs, define.xml, reviewer’s guides, and related documents
• Program and validate SDTM and ADaM datasets
• Perform CDISC conformance checks and address findings
• Develop SAS programs for statistical output reports based on SAP and TLG mock-up shells
• Provide programming support for Clinical Study Reports, integrated safety and efficacy analyses, regulatory safety reports, ad-hoc requests, and exploratory analyses
• Develop and maintain SAS programs for database integrity checks and ongoing data cleaning
• Reconcile CRF and non-CRF data and perform non-CRF data integrity checks
• Generate data listings, summary tables, graphs, and Patient Profiles
• Document data and programming information according to SOPs and WIs
• Achieve audit readiness and defined statistical programming performance indicators
• Maintain knowledge of industry standards and regulatory requirements
• Develop and provide expertise in other programming and system administration areas when required

Statistical Programmer II

• Lead resolution of day-to-day work-related issues and problems
• Ensure quality of deliverables and improve statistical programming efficiency and productivity
• Lead assigned projects using project management skills and statistical programming techniques
• Deliver high-quality project deliverables on time and build client trust and repeat business
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE
• Perform QC reviews of dataset specifications prepared by others
• Program and validate SDTM and ADaM datasets
• Perform CDISC standard-compliant checks on SDTM and ADaM datasets
• Generate, review, and resolve Pinnacle 21 validation issues
• Perform additional QC checks using company Working Instruction checklists
• Review statistical TLGs for overall quality and consistency before internal or client delivery
• Create and QC define.xml files
• Participate in or lead programming teams supporting regulatory submission activities
• Maintain expertise in statistical programming utilities and macros
• Develop new macros and utilities
• Program and perform QC/validation of complex data integrity checks for data quality and scientific data surveillance
• Complete job-required and project-specific training
• Comply with Everest and trial sponsor policies, SOPs, and WIs
• Document data and programming information according to corporate SOPs and guidelines
• Archive SDTM and ADaM datasets and programming information according to archival SOPs and guidelines

Software Engineer jobs in Taiwan

Statistical Programmer II

Senior Statistical Programmer