• Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others. • Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others. • Use SAS/R to develop final analysis datasets such as datasets per SDTM and ADaM specifications. • Program analysis deliverables such as tables, listings, and figures (TLFs) as specified in the study-specific statistical analysis plan (SAP), with oversight by Study Statistician(s) or Senior Programmer. • Collaborate with the Study Statistician(s) to resolve any study-related questions to ensure the programming outputs appropriately reflect the statistical analysis plans (SAP). • Complete programming in accordance with common industry standards and conventions, statistical requirements and specifications, and/or clinical trial sponsor’s requirements. • Generate complete and efficient analysis data models following approved dataset designs or specifications. • Perform validation by acting as double programmer or independent reviewer of analysis datasets and/or statistical output reports generated by other programmers or statisticians. • Develop programming codes and generate complete and accurate statistical output reports in well-defined formats. • Develop programs for centralized statistical monitoring or ongoing data review. • Document data and programming information in accordance with SOPs and guidelines. • Ensure high quality documentation of codes and programs via meticulous organization of codes and documentation. • Continuously review programs and code to identify errors, potential corrections, enhancements or system environment changes. • Use SAS to perform SDTM, ADaM, and table, listing, and figure (TLF) programming, validation and quality control (QC) review. • Archive clinical trial data (study data tabulation models and analysis data models) and programming information. • Identify growth areas for the team and present ideas for process improvements to leader(s). • Proactive contribution to continuous improvement of statistical programming processes and procedures through development of standards, macros, trainings, resources and documentation for the team. • Educate, train and mentor junior programmers and less experienced statistician team members with technical programming guidance. • Review the programming work of other team members via validation and ad hoc review.