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SDTM Technical lead SDTM -Clinical SAS Python

Shrive Technologies LLC Fremont, California, United States · $125K–$135K/yr

IT Services and IT Consulting · 51-200 employees

Sep 25
python Senior (5-10 yrs) Full-time United States
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About the role

The lead will create advanced SAS macros and templates for efficient clinical data processing while acting as the primary programming contact for study teams. They are also responsible for performing peer reviews of code and ensuring full compliance with CDISC standards and regulatory guidelines.

What they look for

SDTM Clinical SAS Python SAS Programming SAS Macros CDISC Standards ADaM FDA Guidelines ICH Guidelines CRF Annotation Data Processing Biostatistics Support Code Review Traceability SAS/BASE SAS/STAT

Requirements

Candidates must have 6-8 years of experience in the clinical domain with strong expertise in SDTM and SAS programming. Proficiency in Python and a deep understanding of FDA/ICH regulatory submission requirements are mandatory.

Full 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.

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