Every Clinical SP Bootcamp part as an
interactive lesson — concept scenes, checkpoint quizzes with graded answers, and hands-on exercises built on a
simulated oncology study. Each lesson pairs with its source article and saves your progress locally in this
browser. No account, no tracking, works on a phone, fully readable without JavaScript.
8
learning lines
21
lessons live
245
scenes
40 · ~7.5h
quizzes · study time
Built by the NDA statistical programming lead behind an FDA-approved product · series archived on
Zenodo
· companion research cited at PharmaSUG 2026 · 7 lessons with video companions
AI-narrated video companions for the lessons — same content, spoken over the slides. Paired articles
embed their video today; lesson-page video slots light up as the new pipeline publishes them.
A systematic path into clinical statistical programming: CDISC fundamentals, modern SCE workflow, and where AI agents fit — every part with runnable takeaways.
Turn a protocol and SAP into a programmer's work list: endpoints, populations, windowing, dates, and query discipline for what the documents leave silent.
ready|11 scenes2 quizzeshands-oncompanion article forthcoming~20 min
SDTM
3/3 live
The CDISC tabulation model — domains, variable patterns, controlled terminology, and mapping specifications.
A worked SDTM AE domain mapping example: MedDRA coding, serious flags, partial ISO dates, AESEQ derivation, SUPPAE, and CORE validation triage from a mock raw extract.
How to write an SDTM mapping specification: column anatomy, a row-by-row VS domain walk, hygiene rules, and how specs become define-XML and machine-usable code.
How ADSL is built: deriving treatment dates and population flags from DM/EX/DS/SV, the one-row-per-subject rule, and the QC checks that catch real discrepancies.
The BDS skeleton behind ADaM analysis datasets: PARAM/PARAMCD/AVAL, baseline flags, change from baseline, and how ADVS and ADLB are built visit by visit.
ADAE from the OCCDS side: one row per event, the AE-to-ADSL merge, treatment-emergent flags driven by TRT01SDT, serious flags, and the QC defects reviewers catch.
ADTTE step by step: event and censoring definitions from the SAP, the censoring date cascade, CNSR semantics, partial dates at the event, and QC listings per subject.
ADRS turns RECIST 1.1 assessments into analysis data: TU-TR-RS traceability, overall response per timepoint, best overall response, PD dates, and PDS hand-off to ADTTE.
ready|11 scenes2 quizzeshands-oncompanion article forthcoming~20 min
TLF
2/2 live
Tables, listings and figures — from mock shell to the RTF output that actually ships.
How clinical TLF outputs ship: reading mock shells, PROC REPORT tables and listings, RTF conventions, and the four-pass QC order that catches defects cheapest first.
SAS macros for clinical TLF: the driver pattern over a metadata table, parameter discipline, %local hygiene, and MPRINT debugging for classic macro failures.
ready|12 scenes2 quizzeshands-oncompanion article forthcoming~22 min
SCE & Modern Workflow
4/4 live
The modern toolchain: computing environments, Git in a GxP world, pipelines as code, and AI inside the boundary.
What a statistical computing environment is for in clinical trials, why desktop SAS and shared drives failed audits, and how cloud SCE workflow changes day one.
Why filename-versioned SAS programs are an audit-trail liability, the minimum Git vocabulary a clinical programmer needs, and how branch-per-output maps to QC.
How to turn the SDTM-to-ADaM-to-TLF chain into pipeline as code: explicit dependencies, pinned environments, hash-verified outputs, and stage-level failure isolation.
The governance question sponsors actually ask about LLMs, how GAMP 5 and CSA risk-based assurance frame AI-assisted programming, and where human accountability sits.
ready|12 scenes2 quizzeshands-oncompanion article forthcoming~22 min
Submission
1/1 live
Define-XML and the Reviewer’s Guide — what regulators open first, and how programmers shape it.
Define-XML 2.1 and the ADRG from the programming side: element-by-element metadata, spec-driven generation, and the defects to sweep before the package ships.
ready|12 scenes2 quizzeshands-oncompanion article forthcoming~22 min
Statistics
1/1 live
The inference layer: p-values and tests you must be able to explain out loud, in plain language.
The tests a clinical SAS programmer must explain: p-values, confidence intervals, Wilcoxon, Fisher, MMRM, log-rank, multiplicity, and the QC craft behind every cell.
ready|12 scenes1 quizzeshands-oncompanion article forthcoming~21 min
Career
2/2 live
What interviews actually ask, and a realistic 2026 roadmap into the role.
How clinical SAS interviews actually work: four rounds from SAS mechanics to GxP habits, real-format questions, and the signals strong answers contain.
What the job is, who gets hired, and how to train for it: a realistic 2026 guide to becoming a clinical statistical programmer, from SAS base to AI-assisted practice.
Same honesty rule as the interactive explainers:
teaching schematics and illustrative values, never presented as measured study data.
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Access
Free to learn, built to last
The full course is free — no account, no paywall on lessons. Learning itself unlocks more:
pass a checkpoint quiz and you can invite friends (and yourself) to the AI tutor.