NoyMed Academy Certified Statistical Programmer
Turn clinical data into CDISC-compliant datasets, tables, listings, and figures.
About this program
A hands-on program in clinical trial programming: SDTM and ADaM, the define.xml, and production of tables, listings, and figures for regulatory submission.
Who it is for
Programmers and analysts (SAS or R) moving into clinical trials, or junior statistical programmers seeking formal grounding.
Prerequisites
- Proficiency in SAS (or R) for data manipulation
- Basic understanding of clinical trial data
- Attention to detail when working from specifications
Curriculum outline
1. Clinical data and CDISC
Why standards exist and how submissions are structured.
Topics: CDASH · SDTM domains · Controlled terminology · Submission packages
2. Building SDTM
Mapping raw CRF data to SDTM.
Topics: Domain design · Supplemental qualifiers · RELREC · Compliance checks (Pinnacle 21)
3. Building ADaM
Analysis-ready datasets from SDTM.
Topics: ADSL · BDS structure · ADAE · Traceability
4. Tables, listings, and figures
Producing and validating TLFs.
Topics: Shell interpretation · Double programming · Validation and QC · Reproducibility
5. define.xml and submission
Documenting the data package.
Topics: define.xml · Reviewer's guide · eCTD module 5 overview
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