Project role: Senior Clinical data standards specialist
Work experiences: 8-10+ years.
Education: Bachelor's / Master's
Work location: PAN India
Mode of work: Homebased
Required skills: 8+ years of experience in Statistical programming domain especially clinical operations (In the area of Data management, Database programming, Data Standards, Statistical programming)
Must have skills:
- Total 8-15 years of experience in Statistical programming domain
- Strong knowledge on SDTM, ADAM, TFL development and validation
- Prior experience working on global library team/Standards team would be good to have
Required qualifications:
- Must have very good understanding of CRF build, SDTM transformation, ADaM datasets and TFLs
- Must have experience in using MDR driven approach especially for CRF build and SDTM transformation
- Must have good understanding of CDISC CDASH and SDTM standards.
- It would be a plus if the candidate has used any MDR products available in market.
- It would be a plus if the candidate has been part of MDR migration activities from legacy to new MDR
- It would be a plus if the candidate has good understanding of USDM (CDSIC’s Unified Study Definition Model, Digital Data Flow concepts, Biomedical concepts etc)