Job Details

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