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.
- M.Sc (Biotechnology)
- B.Sc (Chemistry, Botany and Zoology)
- Software : SAS,
- Database Management : Clinpkus
- Electronic Data Capture (EDC) : Trialstat, Clinplus, Medidata Rave, Inform – Central designer
- Microsoft Office: Word, Excel, PowerPoint, Access