
Principal Data Analyst
7 days ago
This role involves providing high-level programming support for clinical trials, ensuring accurate and high-quality statistical outputs.
- Lead the implementation of CDISC and other regulatory standards
- Develop and maintain internal SAS programming conventions
- Serve as a programming lead on assigned studies
- Coordinate and ensure the accuracy and completeness of activities for assigned support programmers.
- Create and maintain project timelines to deliver results within expected timeframes
- Support the development of tools and macros to improve quality and efficiency of processes
- Prepare programming specifications for SDTM, ADaM and other derived datasets to meet client requirements
- Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:
- Analysis datasets (SDTM, ADaM, other derived datasets)
- Tables, listings and figures
- xml/Reviewer's Guide
- Integrated summaries
- Perform ad hoc analyses of current and legacy databases to identify trends and insights
- Review and provide input on case report form design to optimize data collection
- Mentor junior programmers to enhance their skills and knowledge
- Maintain awareness of scope of work to actual work, alerting management of potential change orders or resourcing needs
- Work effectively with cross-functional teams to ensure accurate and high-quality statistical outputs
- Implement CDISC and other regulatory standards in accordance with industry best practices
- Develop and maintain internal SAS programming conventions to streamline workflows
- Provide expert guidance on programming strategies and solutions
- Develop and maintain project timelines to ensure timely delivery of results
- Collaborate with cross-functional teams to develop and implement effective solutions
- Bachelor's degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree
- Minimum 4 years direct SAS programming experience in pharmaceutical development or CRO environment
- Good knowledge of medical terminology and conduct and analysis of clinical trials
- Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.)
- Excellent oral and written communication skills, organizational skills, and attention to detail are required
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