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About the Role
Premier Research is seeking a Senior R Programmer/Shiny Developer to join their Biostatistics team. This role is crucial in helping biotech, medtech, and specialty pharma companies bring life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. The company emphasizes team member growth, skill development, and work-life balance, valuing individual ideas and contributions to medical innovation.
Responsibilities
- Develops, validates, and supports innovative statistical applications and technical solutions to enhance clinical development and statistical programming.
- Combines expertise in R, R Shiny, SAS, and Python to develop interactive applications, reusable software, automation tools, and data visualization solutions.
- Modernizes statistical workflows by developing validated software solutions to support clinical trial design, analysis, regulatory submissions, and operational excellence.
- Designs, develops, tests, and maintains interactive R Shiny applications for clinical trial activities, ensuring scalability and performance.
- Creates user-friendly applications for statistical review, data exploration, quality control, and reporting.
- Develops reusable Shiny modules and application frameworks.
- Optimizes application performance, scalability, and usability.
- Develops reusable programming utilities using R, SAS, and Python.
- Builds applications to support SDTM and ADaM review, dataset comparison, metadata review, TLF review and quality control, clinical data visualization, and statistical reporting.
- Develops applications in accordance with GxP, Computer Software Assurance (CSA), and company standards.
- Develops and executes application testing, including unit, integration, and regression testing.
- Provides technical consultation on R programming, R Shiny development, and open-source technologies.
- Develops programs to support project deliverables (e.g., ADaM, TLFs).
- Supports study teams with programming activities on projects.
Requirements
- Expertise in R, R Shiny, SAS, and Python.
- Experience developing interactive applications, reusable software, automation tools, and data visualization solutions.
- Experience modernizing statistical workflows.
- Experience developing validated software solutions.
- Experience supporting clinical trial design, analysis, regulatory submissions, and operational excellence.
- Experience developing, testing, and maintaining interactive R Shiny applications.
- Experience creating user-friendly applications for statistical review, data exploration, quality control, and reporting.
- Experience developing reusable Shiny modules and application frameworks.
- Experience optimizing application performance, scalability, and usability.
- Experience developing reusable programming utilities using R, SAS, and Python.
- Experience building applications to support SDTM and ADaM review, dataset comparison, metadata review, TLF review and quality control, clinical data visualization, and statistical reporting.
- Experience developing applications in accordance with GxP, Computer Software Assurance (CSA), and company standards.
- Experience developing and executing application testing, including unit, integration, and regression testing.
- Experience providing technical consultation on R programming, R Shiny development, and open-source technologies.
- Experience developing programs to support project deliverables (e.g., ADaM, TLFs).
- Experience supporting study teams with programming activities on projects.
Skills
- R
- R Shiny
- SAS
- Python
- Statistical Applications
- Technical Solutions
- Interactive Applications
- Reusable Software
- Automation Tools
- Data Visualization
- Clinical Development
- Statistical Programming
- Clinical Trial Design
- Clinical Trial Analysis
- Regulatory Submissions
- Operational Excellence
- GxP
- Computer Software Assurance (CSA)
- SDTM
- ADaM
- TLFs
- Open-Source Technologies
Experience Level
- Senior
About the Company
- Premier Research helps biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
- The company's work is profoundly connected to saving and improving lives.
- Premier Research recognizes team members as its most valuable asset in delivering success.
- The company is committed to helping employees grow, providing skills and opportunities to excel, and offering flexibility and balance.