Prakash P Email & Phone Number

Bengaluru, Karnataka, India

* Perform statistical programming review of case report forms (CRFs), annotated CRFs,database structures, statistical analysis plan (SAP) project documentation such as StatisticalAnalysis Plan (SAP), mock shells, programming specifications and annotated CRFs* Provide the statistical programming support for assigned studies, in both production and QCof analysis dataset specifications, analysis datasets, statistical analysis tables, data listings,figures, and statistical appendices* Provide the status of assigned tasks to Study Lead Programmer and Project Manager* Identify, communicate, and manage study-based risks and issues* Maintain supporting documentation for studies in accordance with SOPs, Work Instructions(WI) to ensure traceability and regulatory compliance* Contribute to development of Statistical Programming standards and processes to improvequality, efficiency, and effectiveness* Ensure audit readiness and quality control for all assigned statistical programmingdeliverables as well as accuracy and reliability of statistical analysis results* Adhere learning and develop knowledge on the latest in CDISC Therapeutic standards, GCPand applicable ICH guidelines

India

* Having 5+ years of experience as Statistical Programmer.* Worked on Phase - I to Phase -III Clinical trial studies.* Experienced in understanding the Study Protocol, Design Document, Statistical Analysis Plan (SAP) and Case Report Form (CRF), CDISC Process (SDTM and ADaM).* Performed CRF Annotations, Developed SDTM and ADaM Specifications, Creating SDTM and ADaM datasets as per Specifications and Statistical Analysis Plan (SAP).* Involved in generation and validation of Tables, Listings and Figures, creation of ADaM and SDTM datasets as per client/sponsor requirements, SAP, and mock shells.* Efficient in both production and validation of analysis datasets, tables, listings, and figures.* Knowledge of creating Define.XML, SDRG and ADRG documents.* Used Pinnacle Enterprise Edition and Pinnacle Community Version to check SDTM compliance.* To identify and document the data issues through appropriate study trackers and report to the Lead Programmer.* To communicate with the Lead Programmer on the status of daily assigned tasks and study related questions.* Responsible for all Statistical Programming activities including Self-Validation checks.* Experienced in developing study specific macros.* Good Knowledge on Macros and used it to automate the work wherever applicable.* To manage and support the study lead on projects and programming activities for single or multiple projects.* To mentor junior programmers working on the project and support training requirements for the trainees/team members.* Any other duties as assigned by the line manager/study leads.

India

* Worked on Phase - I to Phase -III Clinical trial studies.* Experienced in understanding the Study Protocol, Design Document, Statistical Analysis Plan (SAP) and Case Report Form (CRF), CDISC Process (SDTM and ADaM).* Performed CRF Annotations, Developed SDTM and ADaM Specifications, Creating SDTM and ADaM datasets as per Specifications and Statistical Analysis Plan (SAP).* Involved in generation and validation of Tables, Listings and Figures, creation of ADaM and SDTM datasets as per client/sponsor requirements, SAP, and mock shells.* Efficient in both production and validation of analysis datasets, tables, listings, and figures.* Knowledge of creating Define.XML, SDRG and ADRG documents.* Used Pinnacle Enterprise Edition and Pinnacle Community Version to check SDTM compliance.* To identify and document the data issues through appropriate study trackers and report to the Lead Programmer.* To communicate with the Lead Programmer on the status of daily assigned tasks and study related questions.* Responsible for all Statistical Programming activities including Self-Validation checks.* Experienced in developing study specific macros.* Good Knowledge on Macros and used it to automate the work wherever applicable.* To manage and support the study lead on projects and programming activities for single or multiple projects.* To mentor junior programmers working on the project and support training requirements for the trainees/team members.* Any other duties as assigned by the line manager/study leads.

India

* Worked on Phase - I to Phase -III Clinical trial studies.* Experienced in understanding the Study Protocol, Design Document, Statistical Analysis Plan (SAP) and Case Report Form (CRF), CDISC Process (SDTM and ADaM).* Performed CRF Annotations, Developed SDTM and ADaM Specifications, Creating SDTM and ADaM datasets as per Specifications and Statistical Analysis Plan (SAP).* Involved in generation and validation of Tables, Listings and Figures, creation of ADaM and SDTM datasets as per client/sponsor requirements, SAP, and mock shells.* Efficient in both production and validation of analysis datasets, tables, listings, and figures.* Knowledge of creating Define.XML, SDRG and ADRG documents.* Used Pinnacle Enterprise Edition and Pinnacle Community Version to check SDTM compliance.* To identify and document the data issues through appropriate study trackers and report to the Lead Programmer.* To communicate with the Lead Programmer on the status of daily assigned tasks and study related questions.* Responsible for all Statistical Programming activities including Self-Validation checks.* Experienced in developing study specific macros.* Good Knowledge on Macros and used it to automate the work wherever applicable.* To manage and support the study lead on projects and programming activities for single or multiple projects.* To mentor junior programmers working on the project and support training requirements for the trainees/team members.* Any other duties as assigned by the line manager/study leads.