- 9+ years relevant experience of statistics programming and/or clinical drug development process along with leadership experience and hands-on SAS/R programming skills.
- 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 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)