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Statistical Programmer Sr

3 weeks, 2 days ago
India
Senior
Software Engineer
Software Development
Git GitHub GitLab R SAP 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

  • Lead end-to-end programming for multiple clinical studies and serve as the primary client point of contact.
  • Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables.
  • Develop specifications and SAS programs for ADaM datasets supporting trial-level and integrated safety and efficacy analyses.
  • Design, build, maintain, and validate Tables, Listings, and Graphs (TLGs) based on SAPs and biostatistical requirements.
  • Program and quality control 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 in line with industry standards, SDLC practices, and regulatory requirements.
  • Collaborate with cross-functional stakeholders to ensure timely delivery of high-quality study outputs.
  • Maintain project documentation in compliance with SOPs, processes, and quality standards.
  • Write R programs and convert SAS programs to R using AI tools to create datasets and TLFs.

Requirements

  • Bachelor of Science degree in a health-related field, computer science, or equivalent experience; Master’s in Statistics or related science preferred.
  • SAS certification is required.
  • Minimum 8+ years of experience in the pharmaceutical/biotechnology industry or equivalent IT consulting role preferred.
  • Strong experience preparing deliverables for NDA filings.
  • Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11, and clinical trial methodologies.
  • Knowledge of coding dictionaries such as WHO, COSTART, ICD-9, and MedDRA.
  • Knowledge and experience with CDISC data models including SDTM and ADaM.
  • Experience working on multiple clinical protocols simultaneously.
  • Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation.
  • Proficiency with Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
  • Experience with R programming and libraries such as tidyverse, dplyr, admiral, rtables, ggplot2, xportr, and flextable is a plus.
  • Experience using AI tools to improve programming efficiency is a plus.
  • Experience with Git-based version control tools such as GitHub and GitLab is a plus.

Interested in this position?

Apply directly on the company website

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