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Statistical Programmer (data standards)

Statistical Programmer (data standards)

IQVIAKollam, IN
22 hours ago
Job description

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)
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