• Certified SAS Programmer with over 10 years of experience into Clinical SAS programming and experienced in development and validation of SDTM, ADaM and TLF’s with exposure of CDSIC standards. • Good project management skills and ability to work with cross functional teams and global teams. Ability to work as a team while taking the complete accountability for the individual deliverables and entire study deliverables. • Serving as point of contact for offshore team and lead programmer for the study. • Beginner knowledge on R and python. • Manage a team of 5 • Working as point of contact for offshore team for multiple projects as lead which includes leading projects throughout the study deliverable. • Provided Project Management on team projects and communicates actively and frequently with internal and external counter parts. • Develop TFL shell as per study requirement. • Review SAPs and other project related documents. • Develop and maintain SAS programs to create complex SDTM and ADaM datasets and TFLs,and perform QC of SDTM, ADaMs and TFLs. • Analysing clinical trial data and generating clinical reports in the form of tables, listings and figures for safety and efficacy data. • Collaborates effectively within statistical programming and cross-functional project team and with counterparts to achieve project goals • Writing standardized SAS macros for reporting or for derived datasets. • Strong working knowledge on FDA and GCP Guidelines for Phase (I- IV) clinical trials. • SAS programming and analysis support for different phases of clinical trials. • Writing independent codes to check the consistency of statistical values generated as part of quality procedure. • Analysing various tables using data manipulation techniques like merging, appending, concatenating and sorting. • Generating output files in the form of listing, HTML, RTF and PDF formats using SAS ODS. • work closely with Biostatistician to support project-level programming deliverables (for SCS, SCE, RMP), HA interactions and other ad hoc programming requests. • Experience in working with people across globe including Switzerland, US, South Africa, Russia, China and Japan Programmers and Statisticians for Health Authority submissions. • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming. • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs • Provide training on statistical programming related topics. • Manage team workload distribution.