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Clinical Data Analyst

1 week ago

India Atorus Full time

Atorus seeks a highly skilled Lead Statistical Programmer to join our team. As a key member of our data analytics group, you will be responsible for developing and executing statistical programming deliverables for clinical trials.

">">Key Responsibilities:
  • Develop and maintain R programs for data manipulation, transformation, cleaning, and analysis of clinical trial data
  • Create and validate CDISC-compliant datasets (SDTM and ADaM) using R
  • Utilize a wide range of R packages, including tidyverse (dplyr, tidyr, ggplot2), lubridate, metatools, stringr, xportr, diffdf, haven, Tplyr, admiral, and others, to efficiently process and analyze clinical data
  • Implement complex data derivations and transformations as required by the Statistical Analysis Plan (SAP)
  • Perform data quality checks and resolve data discrepancies
  • Loading and integrating data from various sources and platforms
  • Program and validate Tables, Listings, and Graphs (TLGs) for clinical study reports using R and relevant packages
  • Develop and maintain reusable R functions and macros to improve programming efficiency and consistency
  • Ensure all programming deliverables are produced in accordance with SOPs, GCP, ICH guidelines, and sponsor requirements
  • Generating ad-hoc reports and analyses as needed
  • Creating data visualizations and interactive dashboards using R packages like ggplot2 and Shiny (if applicable)
  • Apply a deep understanding of CDISC standards (SDTM and ADaM) in the development of analysis datasets
  • Create and maintain comprehensive documentation for all programming activities, including data specifications, programming code, and validation reports
  • Review and contribute to the development of data standards and programming guidelines
  • Prepare and review Define.xml files
  • Perform rigorous quality control (QC) of all programming deliverables
  • Develop and execute validation plans to ensure the accuracy and reliability of data and analyses
  • Document and resolve any discrepancies or issues identified during the validation process
  • Participate in peer reviews of programming code and documentation
  • Act as a lead programmer for assigned projects, providing technical guidance and mentorship to junior programmers
  • Collaborate effectively with statisticians, clinical data managers, and other team members
  • Participate in project meetings and provide updates on programming activities
  • Manage project timelines and deliverables to ensure timely completion
  • Assume responsibilities for data transfers, including documentation