1. Senior Statistical Programmer Consultant
Working Experience Summary
- 7 years of experience in CDISC Submission Standards and Standardization Process.
- Solid understanding on CDISC SDTM, ADAM, CDASH, Define.xml and Controlled Terminologies.
- Good hands on implementing TUAG on different therapeutics compound like oncology, vaccine, diabetics, cardiovascular, rheumatology.
- Extensive experience in Data mapping/ Data transforming, Data Validation, Quality Check of data, creating reports to check accuracy of data transformation.
- Created and maintained standard document applicable for SDTM and ADAM development.
- Programming experience in TLFs as per shells.
- Solid hands on experience using Base SAS, SAS Macros and SQL.
- Experience in SAS Window and SAS Unix environment.
- Program according to specifications, analysis datasets and reconciliation data for clinical trials and submission activities
- Support quality control and quality audit of deliverables
- Working for life science companies to identify, aggregate and analyze R&D data as per their strategic objectives.
- Involvement in initiatives to include process improvement, standards development and leading the development & support of new tools.
- Bachelor in Computer Science and Engineering
- SAS Base certification
- Lean Six Sigma Green Belt certification