Senior Statistical Programmer

Role & responsibilities:

Must have skills:

• 7+ years relevant experience of statistics programming and/or clinical drug development process along with leadership experience and hands-on 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 new 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)