Sushil Kumar Thangaraj

Experience

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  ICON plc

  Feb 2014 - Feb 2017

  Clinical Data Programmer

  Responsible for specifying, developing, validating, executing and generating clinical data deliverables(SDTM). Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets.Create data set specifications per specified study requirements. Program data sets per specification. Validate data sets per the formal, documented QC process. Create data programming specifications per specified study requirements. Program clinical data programs per specification. Validate clinical data programs per the formal, documented QC process. Create and maintain study documentation as requiredExecute programs and generate clinical data outputs to according to study/client requirements. Participate in testing of clinical data system upgrades and documenting of test scripts when required. Show less

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  Novartis

  Mar 2017 - Aug 2018

  Statistical Programmer

  Contributed end to end statistical programming activities as Statistical Programmer for 6 studies. Build and maintain effective working relationship with cross-functional team. Comply with company, department and CDISC standards and processes, support the review programming specifications as part of the analysis plans. Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for study-documents according to specifications (as assigned)Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Extend knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.Coordinating with various stakeholders involved in the trial, as part of the Trial Programmer role and Core CTT member in Novartis Show less

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  Fortrea

  Aug 2018 - now

  • Manager Statistical Programming

    Jun 2024 - now

  • Principal Stats Programmer

    Sept 2020 - May 2024

  • Programming Lead

    Jan 2019 - Aug 2020

  • Senior Statistical Programmer - 1

    Aug 2018 - Dec 2018