SDTM Lead Programmer - Clinical SAS & Macros Expert

Shrive Technologies LLC; North Wales (Montgomery County); On-site; USD 110,000 - 150,000; Full time

Job summary

Shri ve Technologies LLC is seeking an SDTM expert with in-depth SAS programming experience for clinical trials. The role requires creating advanced SAS macros, templates, and utilities to support biostatisticians and study teams.

Ideal candidates will have 6-8 years in the clinical domain, strong SDTM knowledge, and a solid grasp of CDISC standards (SDTM/ADaM) along with FDA/ICH guidelines.

Qualifications

• 6–8 years of experience in the clinical domain.
• Strong SDTM knowledge.
• Create advanced SAS macros, templates, and utilities for efficient data processing.
• Act as the primary programming contact for biostatisticians and study teams.
• Peer review of code and documentation for accuracy and traceability.
• Review CRF annotations and data specifications.
• Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines.

Responsibilities

• Lead programming activities for SDTM/ADaM datasets in clinical trials.
• Develop SAS macros and templates to streamline data processing.
• Provide coding support and review to biostatisticians and study teams.
• Ensure traceability and accuracy through thorough code reviews.
• Review CRF annotations and data specs for consistency.

Skills

SDTM

Clinical SAS

Python

SAS Macros

Peer review

CDISC standards

FDA/ICH guidelines

Tools

SAS/BASE

SAS/STAT

SAS/MACRO

Job description

Shri ve Technologies LLC is seeking an SDTM expert with in-depth SAS programming experience for clinical trials. The role requires creating advanced SAS macros, templates, and utilities to support biostatisticians and study teams.

Ideal candidates will have 6-8 years in the clinical domain, strong SDTM knowledge, and a solid grasp of CDISC standards (SDTM/ADaM) along with FDA/ICH guidelines.