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Statistical Programmer II

3 weeks, 2 days ago
India
Mid Level
Software Engineer
Software Development
Git GitHub GitLab R Shell Scripting
Apply Now
eClinical Solutions

eClinical Solutions

eClinical Solutions is a leading provider of clinical data management solutions, offering software and services that enable organizations to maximize the value of their clinical data. Their elluminate platform empowers users with complete access to sta...

Professional Services
251-1K
Founded 2006
View All Jobs 10

Description

  • 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 based on biostatistical requirements and statistical analysis plans.
  • Program and QC data listings, summaries, graphs, and statistical models as required.
  • Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting.
  • Generate submission-ready datasets and outputs 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.
  • Write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs.

Requirements

  • Bachelor of Science or Basic Science degree in a health-related field, computer science, or equivalent experience; a master’s degree in statistics or a related science is preferred.
  • SAS certification is required.
  • 4–5 years of experience in the pharmaceutical/biotechnology industry or an equivalent IT consulting role is preferred.
  • Strong experience preparing NDA filings.
  • Strong knowledge of E6, E3, and E9 guidelines, 21 CFR Part 11, and clinical trial methodologies.
  • Knowledge of coding dictionaries such as WHO, COSTART, ICD-9, and MedDRA.
  • Knowledge of CDISC data models such as SDTM and ADaM.
  • Experience working on multiple clinical protocols at the same time.
  • Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation.
  • Experience with R programming and AI tools to improve programming efficiency is a plus.
  • Proficiency in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
  • Experience with R tools and libraries such as tidyverse, dplyr, admiral, rtables, ggplot2, xportr, and flextable.
  • Experience with Git-based version control such as GitHub or GitLab.
  • Excellent written and verbal communication skills in English.
  • Strong attention to detail, multitasking, prioritization, planning, and organization skills.
  • Experience with relational databases, SAS performance optimization, batch processing, shell scripting, and automation is preferred.

Interested in this position?

Apply directly on the company website

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