SDC (Statistics & Data Corporation)

Software Engineer

• Provide statistical programming support for clinical trials
• Perform or oversee statistical programming for clinical trial analysis and reporting on complex, large-scale projects
• Apply statistical methods and provide programming expertise to project teams
• Review Statistical Analysis Plans before programming analyses
• Lead development of SAS macros and utilities
• Generate tables, listings, and figures according to protocols, Statistical Analysis Plans, and client requests
• Participate in statistical program validation and quality control
• Develop or review SDTM aCRF and specifications and ADaM specifications
• Program and validate CDISC SDTM and ADaM datasets
• Review Pinnacle 21 reports for CDISC and FDA compliance
• Develop define.xml, study data reviewer guides, and analysis dataset reviewer guides
• Identify study priorities and communicate with project teams and management
• Manage programming timelines, budgets, client expectations, quality, documentation, and project completion
• Participate in study team meetings
• Collaborate with Clinical Operations, Project Management, and Data Management
• Review study documents including CRFs, edit check specifications, and database design specifications
• Program data-cleaning checks to support Data Management
• Participate in installation and validation of statistical software packages
• Develop and maintain infrastructure for SAS datasets and SAS code
• Mentor junior statistical programmers and provide oversight of their work
• Follow SDC procedures, sponsor requirements, quality systems, data-integrity requirements, and business ethics standards
• Contribute to statistical programming standard operating procedures
• Perform other related duties and maintain compliance with business and regulatory requirements

Principal Statistical Programmer

Data Engineer

• Design and develop data architecture for new and existing applications and data sources
• Establish Data Quality, Data Governance, and Master Data Management best practices
• Design robust and scalable ETL frameworks and data pipelines
• Incorporate new pipelines into existing data models
• Manage and maintain production systems
• Collaborate with internal cross-functional departments to design, develop, and implement data pipelines
• Improve team productivity through better tools and processes
• Follow documentation, coding, and testing best practices
• Develop standard operating procedures for artificial intelligence and data engineering principles within clinical trials
• Prototype new ideas and technologies through proofs of concept and demos
• Mentor other data engineers
• Maintain and develop ETL pipelines
• Maintain the Enterprise Data Warehouse, including updating and translating logic and supporting warehouse servers
• Deliver high-quality software design documentation
• Contribute to standard operating procedures
• Adhere to essential systems and processes required for business and regulatory compliance
• Act as a resource for debugging, code reviews, and software development lifecycle activities
• Perform other related duties

Senior Data Engineer

AI Engineer

• Research, design, develop, and deploy AI/ML models, LLM-based solutions, and agentic workflows for clinical trial data
• Automate ingestion, processing, analysis, interpretation, correlation, and visualization of structured and unstructured clinical data
• Develop NLP pipelines and systems to extract, summarize, and derive insights from clinical datasets
• Build and orchestrate agent-based workflows supporting multi-step reasoning, task execution, and enterprise system/API integration
• Maintain and enhance existing AI/ML models, pipelines, analytics solutions, and applications
• Develop and implement improved tools, frameworks, and processes for AI and software development
• Collaborate with internal cross-functional stakeholders to design AI-driven solutions and understand clinical workflows
• Follow best practices for documentation, coding, testing, and deployment of AI-enabled applications
• Develop and contribute to standard operating procedures for AI, agentic workflows, and software development in clinical trial environments
• Prototype new AI capabilities, tools, and technologies through proofs of concept and demonstrations
• Provide mentorship and technical guidance to engineers and data scientists
• Assist with research and design of new models, architectures, and frameworks
• Deliver technical design and software documentation
• Contribute to standards and best practices
• Maintain compliance with SDC business and regulatory requirements
• Perform other related duties

Senior AI Engineer

• Work as part of a project team to design and implement clinical database applications supporting clinical research and biostatistics analysis
• Work with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing
• Develop data entry screens and programs and data quality edit checks according to specifications
• Perform database structure testing
• Process database programming change requests
• Fully document work according to FDA regulations, guidances, and company SOPs
• Communicate database build, edit check programming, and document review statuses to management and project teams
• Assist in developing, validating, and maintaining clinical databases for clinical trials using validated software applications
• Provide complete and accurate study database documentation consistent with SOPs, study protocols, and data management plans
• Build and validate paper and electronic data capture data entry screens
• Implement and test data quality checks
• Reuse database elements from library structures or similar studies during builds
• Assist in batch loading external vendor data
• Assist in managing user access to clinical databases
• Participate in departmental documentation, training documents, and process guidance
• Participate in other clinical programming and data management activities
• Adhere to SDC quality, data integrity, business ethics, and regulatory compliance systems
• Perform other duties as assigned

Principal Statistical Programmer

Senior Data Engineer

Senior AI Engineer

Clinical Programmer