SDTM, Clinical SAS Programmer

Katalyst CRO; North Wales (Montgomery County); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced SDTM expert with deep SAS programming skills to lead data processing and macro development for clinical trials. You will collaborate with biostatisticians and study teams, review CDISC-compliant specifications, and ensure accuracy and traceability across documentation.

This role requires 10+ years in the clinical domain, strong SDTM knowledge, and proficiency in SAS/Base, SAS/STAT, and SAS/MACRO. Regulatory standards and templates will guide daily work.

Qualifications

• Extensive SAS programming experience in a clinical trial environment.
• SAS macros, templates, and utilities for efficient data processing.
• Deep knowledge of SDTM and CDISC standards for regulatory submissions.
• Familiarity with FDA/ICH guidelines and data specifications.
• Ability to act as programming point of contact for biostatisticians and study teams.
• Peer review of code and documentation for accuracy and traceability.

Responsibilities

• Act as the primary programming contact for biostatisticians and study teams.
• Create and maintain SAS macros, templates, and utilities for data processing.
• Review CRF annotations and data specifications for CDISC compliance.
• Perform peer review of code and documentation for accuracy and traceability.
• Ensure compliance with CDISC SDTM/ADaM and FDA/ICH guidelines.

Skills

SAS programming

SDTM knowledge

CDISC standards

SAS macros

Clinical data analysis

Tools

SAS/Base

SAS/STAT

SAS/MACRO

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.

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.