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About the role
Description: Position : Lead Statistical Programmer Job Location : Bangalore CTC: UPTO 30 LPA Job Responsibilities: - 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 - Other duties as assigned Description: Position : Lead Statistical Programmer Job Location : Bangalore CTC: UPTO 30 LPA Job Responsibilities: - 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 - Other duties as assigned