Statistical Programmer II

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
• Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements
• Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting
• Generate submission-ready datasets and output using industry standards and regulatory requirements
• Collaborate with cross-functional teams to ensure timely delivery of high-quality study outputs
• Use R and AI tools to convert SAS programs and create datasets/TLFs

Requirements

• 4-5 years of experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting
• Advanced SAS programming expertise (Base SAS, SAS/STAT, Macro Language, PROC SQL)
• Strong knowledge of CDISC standards (SDTM, ADaM)
• Experience with NDA filings and regulatory requirements (FDA, PMDA, EMA)
• Knowledge of E6, E3, E9 guidelines and 21 CFR Part 11
• Bachelor's degree in Basic Science, Statistics, Computer Science, or related field
• SAS Certification

Preferred Qualifications

• Master's degree in Statistics or related science
• R programming experience (tidyverse, dplyr, ggplot2)
• Experience using AI tools to gain programming efficiencies
• Knowledge of coding dictionaries (MedDRA, WHO, ICD-9)
• Experience with Git-based version control

About the Company

eClinical Solutions provides advanced clinical technology solutions to help life sciences companies manage and optimize their clinical trials.