Statistical Programmer Sr

Responsibilities

• Lead multiple studies on end-to-end programming while serving as the primary point of contact for clients
• 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 Statistical Analysis Plans (SAPs)
• 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
• Independently write R programs and convert SAS programs to R programs using AI tools

Requirements

• Minimum 8+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role
• Advanced SAS programming expertise (Base SAS, SAS/STAT, Macro Language, PROC SQL, ODS)
• Extensive experience with CDISC standards (SDTM, ADaM)
• Strong knowledge of E6, E3, E9 guidelines and 21 CFR Part 11
• Experience with NDA filings and regulatory submission packages
• Knowledge of coding dictionaries such as MedDRA, WHO, and ICD-9
• Bachelor of Science in health-related fields, computer science, or equivalent

Preferred Qualifications

• Master in Statistics or related science
• SAS Certification
• R programming experience (tidyverse, dplyr, ggplot2)
• Experience using AI tools to gain programming efficiencies
• Experience with Git-based version control (GitHub, GitLab)

About the Company

eClinical Solutions provides advanced software solutions to help clinical research organizations and pharmaceutical companies manage their clinical trials more efficiently.