Statistical Programmer II

About the role

eClinical Solutions is seeking an experienced Statistical Programmer II to support multiple clinical studies. The role involves developing, validating, and delivering high‑quality statistical programming outputs for regulatory submissions, using SAS, CDISC standards, and emerging AI tools.

Key responsibilities

• Develop specifications and SAS programs for SDTM and ADaM datasets.
• Create and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and SAPs.
• Program and QC data listings, summaries, graphs, and statistical models.
• Design reusable SAS macros for Phase I‑IV trial reporting.
• Generate submission‑ready datasets and outputs compliant with FDA, PMDA, and EMA guidelines.
• Collaborate with cross‑functional teams to ensure timely delivery of study outputs.

Required profile

• Basic Science or B.Sc. degree (Master’s in Statistics preferred); SAS certified.
• 4‑5 years of experience in the pharmaceutical/biotechnology industry or IT consulting.
• Strong knowledge of NDA preparation, E6/E3/E9 guidelines, 21 CFR Part 11, and coding dictionaries (WHO, COSTART, ICD‑9, MedDRA).
• Excellent written and verbal communication skills in English.

Required skills

• SAS (Base SAS, SAS/STAT, Macro, PROC SQL, PROC REPORT, PROC SUMMARY, PROC FREQ, PROC TRANSPOSE, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS).
• CDISC standards – SDTM, ADaM, Define.xml.
• R programming (tidyverse, dplyr, admiral, rtables, ggplot2, xportr, flextable).
• Git version control (GitHub, GitLab).
• Pinnacle 21 validation and AI‑assisted programming tools.