• Perform the role of Lead Statistical Programmer for assigned projects • Continually seek ways and means to provide more efficient and effective programming practices • Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis (CDA configuration) module in elluminate • Develop SAS programming to produce SDTM datasets and SDTM datasets for CDA configuration • Develop specifications for Analysis Data Model (ADaM) datasets • Develop SAS programming for ADaM datasets • Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician • Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials • Develop analysis datasets for trial level reporting and integrated safety and efficacy activities • Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming • Develop re-usable utility macros in order to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting • Collaborate with the project team to ensure the deliverables are completed on time with high quality • Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC • Maintain all project documentation as required by SOP and Processes • Mentor statistical programmers • Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures