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Statistical Programmer

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India Atorus Full time US$ 90,000 - US$ 1,20,000 per year

Job Overview :We are seeking a highly motivated and experienced Lead Statistical Programmer with a strong focus on R language to join our dynamic team. The Lead Statistical Programmer will be responsible for the development and execution of statistical programming deliverables for clinical trials, focusing on data manipulation, analysis, and reporting. This role requires a deep understanding of CDISC standards (SDTM, ADaM) and extensive hands-on experience in utilizing R for clinical data processing and analysis.

The ideal candidate will be proficient in creating analysis datasets, tables, listings, and graphs (TLGs) in accordance with regulatory guidelines and project :

  • 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.
  • Load and integrate 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.
  • Generate ad-hoc reports and analyses as needed.
  • Create 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 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.

Qualifications :

  • Bachelor's degree in Computer Science, Statistics, Mathematics, or a related field.
  • Minimum of 4 years of experience in clinical statistical programming or SAS programming.
  • Strong proficiency in R programming language is mandatory.
  • Extensive hands-on experience with CDISC standards (SDTM and ADaM).
  • Demonstrated experience in creating TLGs using R.
  • Expertise in using R packages such as tidyverse (dplyr, tidyr, ggplot2), lubridate, metatools, stringr, xportr, diffdf, haven, Tplyr, admiral, and others.
  • Experience in creating and validating analysis datasets.
  • Strong understanding of clinical trial data and processes.
  • Excellent problem-solving and analytical skills.
  • High degree of accuracy and attention to detail.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Familiarity with SAS and/or Python is a plus.
  • Some travel may be required for meetings.
  • Experience with Shiny for creating interactive dashboards.
  • Experience with regulatory submissions (e.g., FDA, EMA).
  • Project management experience.

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