About the Role
The role involves leading statistical programming activities for clinical trial data, including dataset creation, analysis, and reporting using R and other relevant tools, while ensuring compliance with regulatory standards.
Responsibilities
- Design and implement statistical analysis plans for clinical studies
- Develop and validate datasets, tables, listings, and figures using R
- Ensure programming outputs meet regulatory and internal quality standards
- Collaborate with biostatisticians and data managers to define specifications
- Maintain documentation for programming processes and analysis outputs
- Support audit and inspection readiness for programming deliverables
- Optimize programming efficiency through automation and best practices
- Review work produced by junior programming staff
- Contribute to the development of programming standards and templates
- Ensure adherence to SOPs, CDISC standards, and project timelines
- Participate in cross-functional team meetings
- Troubleshoot data inconsistencies and resolve programming issues
- Assist in the validation of third-party programming outputs
- Stay current with advancements in statistical software and methodologies
- Provide input on project estimates and resource planning
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid or remote work available
Team
Collaborative environment within a dedicated biostatistics team
Why Join Us
- Opportunity to work on diverse therapeutic areas and global studies
- Supportive environment that values professional development
- Exposure to innovative statistical methods and real-world data projects
Technology Stack
- Primary use of R for statistical programming
- Integration with Git for version control
- Use of RStudio and related IDEs
- Collaboration tools for remote teams
Available for qualified candidates