SDTM Technical lead (Clinical SAS, Python)

Shrive Technologies LLC; Upper Gwynedd Township (Montgomery County); On-site; USD 110,000 - 140,000; Full time

Job summary

Shrive Technologies LLC is seeking an experienced SDTM expert with deep SAS programming skills in a clinical trial setting. The role focuses on SDTM, ADaM, and regulatory alignment, with strong emphasis on SAS macros and templates to streamline data processing.

The candidate will act as the primary programming contact for biostatisticians and study teams, perform peer reviews, and ensure CDISC standards and FDA/ICH guidelines are met across studies.

Qualifications

• 6-8 yrs of experience in clinical domain.
• Strong knowledge of SDTM.
• Create advanced SAS macros, templates, and utilities for efficient data processing.
• Act as the primary programming point of 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 SDTM/ADaM and FDA/ICH guidelines.

Responsibilities

• Act as the primary programming liaison for biostatisticians and study teams.
• Perform peer review of code and documentation for accuracy and traceability.
• Review CRF annotations and data specifications.
• Ensure CDISC SDTM/ADaM compliance with FDA/ICH guidelines.

Skills

SDTM

Clinical SAS

Python

Tools

SAS/BASE

SAS/STAT

SAS/MACRO

CDISC standards

Job description

Mandatory skills- SDTM, Clinical SAS, Python Job Description- Looking for SDTM experts having in-depth knowledge of sas programming(macro's)

• Must have 6-8 yrs of exp in clinical domain
• Strong knowledge of SDTM
• Create advanced SAS macros, templates, and utilities for efficient data processing
• Act as the primary programming point of contact for biostatisticians and study teams
• Perform peer review of code and documentation for accuracy and traceability
• Review CRF (Case Report Form) annotations and data specifications
• Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines

Skill:

• Extensive programming experience in a clinical trial environment (CRO/Pharma)
• Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO
• In-depth knowledge of CDISC standards and regulatory submission requirements