wal615

Pharma Stats Skill — Development skill for Claude Code

Development community

Claude Code skill and project template for pharma biostatistics: human-in-the-loop SDTM to ADaM to TLF workflows in SAS/R, with re-read-before-edit, user-runs-code, decision logs, and QC commands and.

How to install Pharma Stats Skill

This entry records only its repository, not the path inside it, so there is no exact command to give. Open wal615/pharma-stats-skill and copy the folder into ~/.claude/skills/, or the file into ~/.claude/agents/.

What Pharma Stats Skill does

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README

Pharma Stats Skill for Claude Code

A Claude Code skill and project template for biostatisticians doing clinical trial statistical programming (SDTM → ADaM → TLF) in SAS or R.

The idea

End-to-end AI derivation fails because a derivation is a chain of small hidden assumptions, and the agent guesses each one silently. This skill flips the order: **decide first, derive second.** The statistician makes the decisions and runs the code; Claude Code writes small, self-contained snippets. Every decision is visible in the data before it becomes code, and recorded in a decision log.

What's inside

SKILL.md — the skill itself: the hybrid loop, the non-negotiable rules, and how to use the commands and agents.
templates/ — a drop-in project template:
- Layered CLAUDE.md files (root + adam/ + tlf/ + sdtm/ + specs/)
- docs/STUDY_MAP.md — project index, maintained by hand
- docs/DECISIONS.md — decision log / audit trail
- .claude/commands/ — /check-log, /qc-tlf, /new-adam
- .claude/agents/ — study-explorer, tlf-reviewer
- .claude/settings.json — permissions (Rscript/SAS runs need approval) and hooks (a reminder to re-read a file before every edit)

Use it as a skill

Copy this folder to `~/.claude/skills/pharma-stats/` (all projects) or to a project's `.claude/skills/pharma-stats/`, then invoke it with `/pharma-stats` or let Claude Code pick it up when the task matches.

Use it as a project template

Copy the contents of `templates/` into your study project root and replace every `[placeholder]` with the real study information. Start with `study-explorer` to map a new study into `docs/STUDY_MAP.md`.

Core rules (enforced by the template)

Re-read a file before editing it — the user edits by hand in RStudio, and a remembered version may be stale.
The user runs the code by default; Claude Code runs it only when explicitly asked.
Every snippet is self-contained: it loads its own libraries and da