CDISC Standard Implementation Project

We are a CRO (Contract Research Organization) and we are looking for someone to help us with an open-label, non-randomized, multi-centre, Phase 1 study to assess the pharmacokinetics, safety and tolerability of ABC drug following a single oral 80 mg dose to patients with advanced solid tumors and normal renal function or severe renal impairment.

You will receive a list of clinical data sets that were captured in our eCRF, and you will help to convert the data into the relevant SDTM and ADaM data sets, based on the current CDISC standard and the SDTM/ADaM specifications.

You will also create the tables, listings and figures (TLF), based on the Analysis Data Model data sets.

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Project List:

SDTM Data Sets:

• Creating SDTM DM data set
• Creating SDTM AE data set
• Creating SDTM EX data set

ADaM Data Sets:

• Creating the ADAE data set
• Creating the ​ADEX data set

Tables, Listings and Figures

• Creating Statistical Tables
• Creating Subject Data Listings
• Creating Figures