SDTM, Clinical SAS Programmer

Creative Solutions Services, LLC; North Wales (Montgomery County); On-site; USD 110,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Senior SAS Programmer with 10+ years in the clinical domain to drive SDTM/CDISC workstreams in a CRO/Pharma setting. You will lead complex SAS programming efforts and mentor junior staff.

You will develop advanced SAS macros and templates, support biostatisticians and study teams, review CRFs and specifications, and ensure compliance with FDA/ICH guidelines and CDISC standards.

Qualifications

• 10+ years of clinical domain experience.
• Proven SAS programming expertise in CRO/Pharma settings.
• Strong knowledge of SDTM and ADaM datasets.

Responsibilities

• Serve as primary programming contact for biostatisticians and study teams.
• Create advanced SAS macros, templates, and utilities for data processing.
• Peer review of code and documentation for accuracy and traceability.
• Review CRF annotations and data specifications to ensure CDISC compliance.
• Ensure adherence to FDA/ICH guidelines and SDTM/ADaM standards.

Skills

Clinical trial programming

SAS/Base

SAS/STAT

SAS/MACRO

CDISC standards

Job description

Job Description:

• Looking for SDTM experts having in-depth knowledge of SAS programming(macro's).


• Must have 10 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.