Excelya

Lead SDTM Programmer

Excelya

full-time

Posted on:

Origin:  • 🇮🇳 India

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Job Level

Senior

Tech Stack

ETLGoogle Cloud Platform

About the role

  • Provide SDTM Programming input for Data Management activities dedicated to one Sponsor
  • Ensure all clinical programming aspects per client SOPs are delivered to high quality
  • Responsible for building SDTM data models using SAS and other ETL tools
  • Set up SAS QC environments and programs for data set validation
  • Apply deep understanding of SDTM implementation in Oncology and Cardiovascular therapeutic areas
  • Use Pinnacle 21 Enterprise for data set validations and ensure IG requirements are met
  • Maintain regulatory compliance through knowledge of ICH GCP and relevant ICH, EU, or FDA guidelines
  • Collaborate within a dynamic team to drive innovation and contribute to clinical research objectives

Requirements

  • Seven or more years of experience in SDTM/ SAS Programming
  • Deep understanding of SDTM and its implementation in Oncology and Cardiovascular TA’s
  • Able to set up SAS QC environment & programs for data set validation
  • Knowledge of Pinnacle 21; able to use Pinnacle 21 Enterprise for data set validations
  • Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance
  • Technical inclination to learn other ETL tools to develop Data sets
  • Bachelor’s degree qualification
  • Fluent in English (written and spoken); effective verbal and written communication skills