Principal Developer, Data Visualization and Application Development

Duties:

· Create and maintain applications for required projects within the Data Visualization and Application Development team.

· Responsible for creating and maintaining macros and programs used to create statistical programming deliverables, including SDTM.

· Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration.

· Develop programs and utilities using various tools and languages to support integration.

· Maintain existing and develop new metadata tools to integrate across the systems in the study data flow and enable automation of SDTM including supporting overall Biogen efforts in streamlining data flow and data review.

· Create and maintain programs to support and enhance under-represented population in Biogen’s clinical trials.

· Create and develop Dashboard for overall utilization and workload of functional service providers for better assessment and redistribution of tasks and ownership. · Develop, project manage and maintain SharePoint site for functional groups.

· Work on complex algorithms and coding to integrate all SDTM specifications and database specifications.

· Build governance database to create a repository of all governance requests such that the governance requests and guidance can be tracked.

· Create and provide training on “R” to SAS programmers.

Telecommuting permitted up to 20%.

Minimum Requirements:

Employer will accept a Bachelor’s degree (or foreign equivalent) in Data Analytics, Information Systems, Information Technology or related field, and 4 years of experience in the job offered or in a Principal Developer, Data Visualization and Application Development-related occupation.

Position requires 24 months of experience in the following:

· Working with CDISC data standards to ensure compliance and consistency of data analysis in clinical research.

· Developing applications that facilitate data or components of a Clinical Study Report (CSR) intended for submission to a regulatory body.

· Working within a GxP-compliant computing environment including knowledge of Good Clinical Practice (GCP) requirements for software.

· Regulatory requirements for software used in clinical trials and submissions, including familiarity with FDA 21 CFR Part 11.

Position also requires 4 years of experience in the following:

· Developing and optimizing R programs using packages including dplyr, data.table, and tidyr to efficiently extract, transform, and analyze large datasets, integrating results for advanced statistical modeling and visualization.

· Creating dynamic visualizations including Plotly, ggplot2, RColorBrewer, and Leaflet to enhance data interpretation.

· Generating and maintaining markdown validation reports using knitr.

· Developing custom R functions using packages including purrr, dplyr, and stringr to enhance reusability, streamline workflows, and standardize analytical processes across projects.

· Building data-driven applications with the R Shiny framework and automating reporting dashboards, ensuring seamless user interactivity and functionality.

· Performing rigorous QC/QA validation checks using R packages and producing consolidated report outputs.

· Upholding strong documentation practices, adhering to best coding standards in R, and managing version control with Azure DevOps or GitHub Repos.

· Independently managing software projects and moving them to completion and demonstrating project management skills in a data/software environment.

· Assessing data models and then applying them to existing data.

· Working with relevant stakeholders to identify user requirements and working independently to create/optimize solutions.

Telecommuting permitted up to 20%.

Salary: $122,000 to $177,00/year

Hours: 9:00 a.m. to 5:00 p.m. Monday – Friday, approximately 40 hours/week.

 

Job Level: Management

Additional Information

The base compensation range for this role is: -