Programming & Data Standards

TipWhat this section covers

This section presents a standards-driven programming portfolio focused on SDTM, ADaM, and TLF delivery with a strong emphasis on traceability, QC-first execution, and submission readiness.

Overview

My programming and data standards work is organized around the core clinical reporting workflow:

  • SDTM — standardized tabulation datasets for submission and traceable source representation
  • ADaM — analysis-ready datasets designed for inferential reproducibility and TLF generation
  • TLF — tables, listings, and figures aligned to SAP/TLF shells and review-ready outputs

Across all three areas, I focus on:

  • Standards compliance (CDISC-aligned structure and metadata discipline)
  • Traceability (clear links from source → SDTM → ADaM → TLF)
  • Quality control (validation checks, reproducibility, and reviewer-friendly organization)
  • Submission readiness (define.xml support, reviewer guides, and package completeness)

What you’ll find in this section

SDTM

  • Domain-focused examples (e.g., DM, AE, VS)
  • Build quality and QC workflows
  • Validation and standards alignment
  • Submission support artifacts (CRF, define, SDRG)

ADaM

  • Analysis dataset examples (e.g., ADSL, ADAE, ADVS, ADTTE)
  • Derivation traceability and analysis readiness
  • Validation and QC practices
  • Submission support artifacts (define, ADRG)

TLF

  • Shell-aligned output planning and implementation
  • Example tables, figures, and listings
  • Delivery organization and output review readiness
  • Traceable linkage to ADaM/SAP intent

Working style

I use a spec-driven, QC-first workflow designed to support reliable delivery:

  • Start from standards/specifications and shell expectations
  • Build with traceability in mind (variables, derivations, output links)
  • Apply validation checks early and throughout
  • Organize deliverables for efficient review and submission support