Principal Statistician - Computation (r3)

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

Principal Statistician - Computation (R3) at Eli Lilly to collaborate on statistical analysis plans, select statistical methods, perform data analysis, and apply SAS programming and statistical methodology. Requires a Master's degree in Statistics or related field, experience with SAS and R, clinical trial data standards (CDISC SDTM/ADaM), regulatory guidelines (ICH E9/E3), version control (Git/GitHub), and reporting tools (Pinnacle 21, Spotfire, SAS ODS Graphics, R Markdown).

What you'd actually do

  1. collaborate with other statistical colleagues to provide input to statistical analysis plans.
  2. Assist in selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created.
  3. Collaborate with data management in the planning and implementation of data quality assurance plans.
  4. Apply SAS programming and statistical methodology to new and varied methods.
  5. Understand relevant disease states in order to enhance the level of customer focus and collaboration.

Skills

Required

  • Master’s degree in Statistics, Biostatistics, or related field
  • SAS programming
  • R programming
  • Clinical trial data standards (CDISC SDTM/ADaM)
  • Pinnacle 21
  • ICH E9
  • ICH E3
  • Git/GitHub
  • Spotfire
  • SAS ODS Graphics
  • R Markdown

What the JD emphasized

  • Master’s degree in Statistics, Biostatistics, or related field
  • academic or employment experience in statistical programming language/software such as SAS (Base, Macro, and STAT modules) and R (tidyverse, ggplot2, and Shiny)
  • experience with clinical trial data standards, including CDISC SDTM and ADaM datasets, and use of Pinnacle 21 for compliance validation
  • experience with clinical study deliverables, including generating tables, figures, and listings (TFLs), and statistical outputs for CSR and regulatory submissions (e.g. FDA, EMA)
  • experience with regulatory guidelines, such as ICH E9 (Statistical Principles for Clinical Trials) and ICH E3 (Structure and Content of Clinical Study Reports)
  • experience with version control and collaboration tools, including Git/GitHub for source code management
  • experience with Spotfire, SAS ODS Graphics, and automating report generation using R Markdown or SAS ODS