Must have skills:
9+ years relevant experience of statistics programming and/or clinical drug development process along with leadership experience and hands-on SAS/R programming skills.
Solid 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 valuable 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 recent MDR
It would be a plus if the candidate has good understanding of USDM (CDSICs Unified Study Definition Model, Digital Data Flow concepts, Biomedical concepts etc)