- Lead development and implementation of clinical solutions for global technical-services issues involving EDC tools and SAS programming
- Lead development of visual analytics dashboards using Spotfire or Tableau
- Complete assigned work using Medidata Rave, Oracle Inform, or proprietary software according to Fortrea SOPs, work instructions, project guidelines, and Good Clinical Practices
- Perform post-production EDC database changes and enhancements to SAS programs, including edit checks, listings, protocol deviations, and datasets
- Meet with Data Managers to discuss contractual obligations and timelines
- Act as subject matter expert and point of contact for EDC and SAS technical-services issues
- Provide statistical programming support for SDTM/client standards datasets
- Develop and validate custom/complex SDTM domains and handle external data and reconciliations
- Develop and implement SDTM automation, standardization, and best programming practices
- Plan, execute, and oversee study programming activities, including resource estimation, timelines, quality, departmental/client interaction, and related activities
- Perform testing, troubleshooting, error fixing, and documentation
- Participate in process reviews and adoption of best practices
- Conduct peer review and quality control of study designs
- Participate in software validation and updates
- Maintain awareness of EDC product developments
- Forecast resources and allocate project activities to team members
- Identify trends, generate reports/metrics, demonstrate programming processes to sponsors/auditors, and assist with ECRF and study-document design
- Perform other assigned duties
Requirements
- Must have hands-on experience in custom function programming
- University / college degree in life sciences, health sciences, information technology or related subjects preferred
- Experience and/or education plus relevant work experience equating to a bachelor's degree accepted in lieu of a bachelor's degree
- Fluent in English, both written and verbal
- 5 to 8 years of relevant work experience in data management and database support, SAS Programming, Spotfire, or Tableau development
- Good problem-solving skills and a proactive approach
- Good oral and written communication skills
- Basic knowledge of clinical trial processes, data management, biometrics, and systems applications preferred
- Demonstrated ability to work in a team environment
- Demonstrated ability to work independently under supervision
- Proven interpersonal skills
Core Competencies
Demonstrates expertise in SAS Programming, EDC tools, and visual analytics development using Spotfire or Tableau, while ensuring compliance with Good Clinical Practices and project guidelines. Proven ability to lead programming activities, manage resources, and communicate effectively with stakeholders.
Highest-signal resume keywords
- SAS Programming
- EDC Tools
- Spotfire Development
- Tableau Development
- Clinical Trial Processes
Hard Skills
- Custom Function Programming
- Statistical Programming
- SDTM Automation
- Database Support
- Data Management
Soft Skills
- Problem-Solving Skills
- Oral Communication Skills
- Written Communication Skills
- Interpersonal Skills
- Team Collaboration
Industry Keywords
- Good Clinical Practices
- Biometrics
- Clinical Solutions
- Data Management
- Study Programming
Tools & Technologies
- Medidata Rave
- Oracle Inform
- SAS
- Spotfire
- Tableau