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)