Statistical Programmer (data standards)

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)