1. CDISC SDTM Expert/Senior Database Programmer

Working Experience Summary
  • Overall 13 years of experience in Life sciences – Database operations involving successful Design, Build and Execution of projects on major platforms.
  • Around 5 years of experience in clinical programming and & CDISC – CDASH, SDTM Implementation for CDM projects.
  • Broad experience on working with platforms like Medidata RAVE, Inform  - Central Designer 2.0, Inform – Central Designer 2.1, TrialStat  and Clinplus.
  • Successfully executed multiple projects for major Strategic Global Clients involving vast therapeutic areas like Oncology, Dermatology, Cardiovascular, Diabetics, Orthotropics (RA), Hematology & Immunology.
  • Extensive knowledge in generating SAS listings and reports.
  • Hands on project management, Timely delivering of projects, Project Co-ordination.
  • Proven ability to establish and maintain highly productive working relationships with project teams and clients while working with Global Cross functional teams.
  • Responsible for Setting up Modelling Notifications, Administrative Rights and maintenance of Rights and Users throughout the study.
  • Hands on  developing SDTM mappings process, data transformations, review and guide team on implementation.
  • Implemented CDASH & SDTM standards for study start-up activities and post data exports.
  • Key member in data standard development teams – CRF templates in compliance with CDISC – CDASH, SDTM guidelines.
  • Involved in MDR implementation & data transformations by using SAS macros/programs.
  • Be capable of understanding a protocol and providing feedback to the project team/CRF design group on design issues, with regards to the protocol requirements.
  • Hands on experience in data mining and data management related to disease/target centric databases.
  • Experience on Gene Annotation as per the standards.
  • Experience in Curation and Quality analysis of the data.

Educational Background
  • M.Sc (Biotechnology)
  • B.Sc (Chemistry, Botany and Zoology)

Technical skills
  • Software : SAS,
  • Database Management : Clinpkus
  • Electronic Data Capture (EDC) : Trialstat, Clinplus, Medidata Rave, Inform – Central designer
  • Microsoft Office: Word, Excel, PowerPoint, Access