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Senior Statistical R Programmer

Senior Statistical R Programmer

Katalyst CROSan Francisco, CA, United States
5 days ago
Job type
  • Full-time
Job description

Overview

Join to apply for the Senior Statistical R Programmer role at Katalyst CRO .

Responsibilities

  • Lead statistical programming deliverables including : generation of data visualizations or summary reports to support internal decision making and regulatory interactions (IND / CTA filings, annual safety reporting, etc.); providing input for statistical analysis plans, study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management on case report form design, data review plans, and external data transfer specifications; collaboration with the study team to review data and manage timelines; oversight of Biometrics CRO deliverables.
  • Design, develop, and validate CDISC analysis data (i.e., SDTM, ADaM) for use with statistical reporting code and analytics applications.
  • Develop and manage reusable code for interactive data visualization, exploratory analysis, and statistical summaries in clinical study reports.
  • Work with the Biometrics Team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.
  • Support the Biometrics Team in efforts to build, maintain, and continuously improve an R infrastructure that is suitable for regulatory submission work.

Requirements

  • At minimum, a bachelor's degree in Statistics, Biostatistics, Data Science, Mathematics, or a related field is required.
  • At least five years of experience as a Statistical Programmer on a Biotech / Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
  • Demonstrated ability to effectively lead projects and collaborate cross-functionally.
  • Exceptional R programming skills (including tidy verse, Markdown, Shiny, HTML widgets, development of R packages, working with IT staff to build R infrastructure), experience applying software development concepts, well versed in reproducible research methods, and proficiency in using code repositories like Git / GitHub (or similar tools) for collaboration and versioning of operational, robust, and well documented code.
  • Able to work in a Linux / Unix environment (including shell scripting).
  • Applied experience with SDTM or ADaM CDISC data.
  • Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
  • Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.

    • Seniority level

  • Associate

    • Employment type

  • Contract

    • Job function

  • Information Technology

    • Industries

  • Pharmaceutical Manufacturing

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