Senior SAS Programmer

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
• 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

Statistical Analysis System (SAS), Statistics, SAP, Documentation, Statistical Analysis System (SAS), Data Sets, Pinnacle, Training Data Sets, Analysis Skills, Data Modeling