Be responsible for designing, developing, validating, and documenting SAS programs to generate summary tables, listings, graphs, and derived datasets as specified in the Statistical Analysis Plan (SAP)

• Be responsible for creating and validating (through Pinnacle 21 or other tools) the Study Data Tabulation Model (SDTM) and the Analysis Data model (ADaM) datasets
• Act as the core project team member and manage all statistical programming activities
• Serve as the study programmer to design and specify the overall approach to a project’s programming tasks
• Provide statistical programming liaison with the client, statistician, and inputs for SAPs.
• Create and maintain programming tracking documentation
• Create, test, and maintain SAS programs for Clinical studies
• Validate and transform datasets as per client assignment specifications
• Validate tables, listings, and graphs as per client assignment specifications
• Co-ordinate with the client and US-team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
• Be responsible for assisting statisticians in the development and review of SAPs and Programming specifications
• Have an expert understanding of all current SDTM and ADaM domains
• Be responsible for creating Case Report Tabulation Data Define Specification (CRTDDS) – Define.xml (metadata for the SDTM and ADaM)
• Create annotated CRFs by following the SDTM
• Create the Trial design Model (TDM)
• Follow necessary departmental SOPs or Client specific SOPs and relevant regulatory guidelines (ex. ICH E9, E6 etc.)
• Support assignments on single or multiple projects
• Create standard macros and applications to improve the efficiency of the department
• Be responsible for sharing better practices, guide and mentor less experienced Statistical programmers, peer-review programs written by less experienced statistical programmers
• Be responsible for continuous development of own skills according to Individual Development Plan
• Facilitate best practices in order to increase quality, efficiency, and productivity
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Desirable Skills and Experience

• Experience in SAS Programming is required
• Be responsible for designing, developing, validating, and documenting SAS programs to generate summary tables, listings, graphs, and derived datasets as specified in the Statistical Analysis Plan (SAP)
• Be responsible for creating and validating (through Pinnacle 21 or other tools) the Study Data Tabulation Model (SDTM) and the Analysis Data model (ADaM) datasets
• Act as the core project team member and manage all statistical programming activities
• Serve as the study programmer to design and specify the overall approach to a project's programming tasks
• Provide statistical programming liaison with the client, statistician, and inputs for SAPs.
• Create and maintain programming tracking documentation
• Create, test, and maintain SAS programs for Clinical studies
• Validate and transform datasets as per client assignment specifications
• Validate tables, listings, and graphs as per client assignment specifications
• Co-ordinate with the client and US-team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
• Be responsible for assisting statisticians in the development and review of SAPs and Programming specifications
• Have an expert understanding of all current SDTM and ADaM domains
• Be responsible for creating Case Report Tabulation Data Define Specification (CRTDDS)
• Define.xml (metadata for the SDTM and ADaM) Create annotated CRFs by following the SDTM
• Create the Trial design Model (TDM) Follow necessary departmental SOPs or Client specific SOPs and relevant regulatory guidelines (ex. ICH E9, E6 etc.)
• Support assignments on single or multiple projects
• Create standard macros and applications to improve the efficiency of the department
• Be responsible for sharing better practices, guide and mentor less experienced Statistical programmers, peer-review programs written by less experienced statistical programmers
• Be responsible for continuous development of own skills according to Individual Development Plan Facilitate best practices in order to increase quality, efficiency, and productivity
• Desirable Skills and Experience Experience in SAS Programming is required