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About This Role:
- 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 group.
- 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%.
Required Skills:
Employer will accept a Master’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%.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Biogen Cambridge, Massachusetts, USA Office
225 Binney Street, Cambridge, MA, United States, 02142
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