SDTM Technical lead SDTM -Clinical SAS Python

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

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

• 1.Must have 6-8 yrs of exp in clinical domain
• 2.Strong knowledge of SDTM
• 3.Create advanced SAS macros, templates, and utilities for efficient data processing
• 4.Act as the primary programming point of contact for biostatisticians and study teams
• 5.Perform peer review of code and documentation for accuracy and traceability
• 6.Review CRF (Case Report Form) annotations and data specifications.
• 7.Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines
• Skill:
  • 1.Extensive programming experience in a clinical trial environment (CRO/Pharma).
  • 2.Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
  • 3.In-depth knowledge of CDISC standards and regulatory submission requirements.