Principal, Data Manager - Consultant
Alira Health
Google Cloud Platform
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Lead and support all statistical programming activities aligned with project strategies
- Use R to create high-quality clinical deliverables and validate outputs using SAS
- Develop Shiny Apps, and R packages; work on modern R framework for app building
- Develop Tables, Listings, and Figures (TLFs) using R
- Author and maintain reusable R macros/functions
- Validate R-based outputs and deliverables against SAS results or legacy code
- Customize outputs and visualizations based on statistical analysis plans and audience requirements
- Take ownership of programming deliverables for clinical studies or projects
- Actively contribute to process improvement, programming standards, and best practices
- Ensure compliance with CDISC standards and maximize automation and reusable code
- Coordinate programming activities, anticipate resource needs, and support timelines
- Proactively identify and communicate risks or issues related to assigned studies/projects
Requirements
- Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field
- 8+ years of clinical programming experience (CDISC) with Bachelor’s or 7+ years with Master’s degree
- Strong experience with R, including writing custom macros/functions and automating workflows
- Ability to validate deliverables using SAS
- Proven experience in the Hematology/Oncology therapeutic area
- Hands-on experience with ISS and ISE deliverables
- Solid understanding of ICH-GCP, clinical trial processes, and regulatory requirements
- Strong communication, collaboration, and organizational skills
- Up-to-date knowledge of clinical data standards and submission requirements (e.g., CDISC SDTM, ADaM)
