SAS Clinical Programmer, SDTM & CDISC
Overview
You will own SDTM deliverables end-to-end, building advanced SAS macros, templates, and utilities for clinical data processing at Katalyst Healthcares & Life Sciences. You will partner with biostatisticians and study teams as the primary programming contact, ensuring traceability and accuracy in every deliverable. With 10+ years in the clinical domain, you will enforce CDISC standards (SDTM/ADaM) and FDA/ICH compliance across studies. This contract role in Philadelphia puts your expertise at the core of regulatory submissions.
What You'll Do7
- 1Build advanced SAS macros, templates, and utilities to accelerate data processing across studies.
- 2Drive SDTM mapping and validation, ensuring compliance with CDISC and FDA/ICH guidelines.
- 3Lead as primary programming contact for biostatisticians and study teams, translating analysis needs into specs.
- 4Debug and refine SAS/BASE, SAS/STAT, and SAS/MACRO code to deliver clean, validated datasets.
- 5Review CRF annotations and data specifications against study protocols.
- 6Peer-review code and documentation for accuracy, traceability, and audit readiness.
- 7Ship SDTM datasets and supporting documents for regulatory submissions within tight timelines.
Requirements7
- 110+ years in clinical domain programming within CRO or Pharma.
- 2Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
- 3In-depth knowledge of CDISC standards (SDTM/ADaM) and regulatory submission requirements.
- 4Proven ability to create advanced SAS macros, templates, and utilities.
- 5Strong understanding of CRF annotations and data specifications.
- 6Experience as primary programming contact for biostatisticians and study teams.
- 7Track record of peer-reviewing code and documentation for accuracy and traceability.
Salary Insight
Salary not disclosed in listing
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