Principal Developer, Data Visualization and Application Development

Biogen•Cambridge, MA

2d•Hybrid

About The Position

This role is within the Data Visualization and Application Development team, focusing on creating and maintaining applications, macros, and programs for statistical programming deliverables, including SDTM. The position involves integrating new data standards, developing programs for system integration, and maintaining/developing metadata tools to streamline data flow and automation. A key aspect is creating programs to support under-represented populations in clinical trials and developing dashboards for workload management. The role also includes project management for SharePoint sites, working on complex algorithms for SDTM and database specifications, building a governance database, and providing R training to SAS programmers. Telecommuting is permitted up to 20%.

Requirements

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.
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.

Responsibilities

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.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Cash bonus
Equity incentive opportunities