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)