Senior Statistical Programmer - SDTM/ADaM Expert (R & AI)

Eclinical Solutions

United States

Remote

USD 130,000 - 190,000

Full time

5 days ago

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Job summary

Eclinical Solutions is seeking an experienced Senior Statistical Programmer to lead end-to-end programming for multiple clinical studies, delivering SDTM/ADaM datasets, TLGs, and Define.xml for regulatory submissions.

You will develop specifications, reusable SAS macros, and collaborate with cross-functional teams while leveraging R and AI tools to enhance efficiency and ensure high-quality deliverables in a fast-paced environment.

Qualifications

Bachelor of Science degree in health-related fields, computer science or equivalent; Master in Statistics preferred.
SAS Certified.

Responsibilities

Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables.
Create specifications and SAS programs for ADaM datasets supporting trial-level reporting and integrated safety and efficacy analyses.
Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and SAPs.
Program and QC data listings, summaries, graphs, and statistical models as required.
Design and maintain reusable SAS macros to support Phase IIV clinical trial reporting.
Generate submission-ready datasets and output using industry standards, SDLC practices, and regulatory requirements.
Collaborate with cross-functional teams to ensure timely delivery of high-quality study outputs.
Maintain project documentation in compliance with SOPs, processes, and quality standards.
Ensure adherence to eClinical Solutions and industry guidelines, procedures, and regulatory expectations.
Ability to independently write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs.