Must Have Skills: Clinical SAS/DM SAS/SAS Macros/ SAS Programming (clinical)
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Key Responsibilities:
- Support Clinical Data Management activities within Biometrics.
- Collaborate with programmers, data managers, statisticians, safety, regulatory, and project teams.
- Ensure clinical data quality, accuracy, and consistency.
- Provide programming support as per study timelines and specifications.
- Contribute to data validation and transfer specifications.
- Support clinical data reporting and regulatory submissions.
- Monitor data quality and resolve study data issues.
- Act as Study Clinical Programmer.
- Review work completed by supporting programmers.
- Attend study team meetings and provide inputs.
- Bachelor's degree in Mathematics, Computer Science, or equivalent.
- Solid verbal and written communication skills.
- Knowledge of pharmaceutical clinical development and regulatory submissions.
- Understanding of statistical concepts and techniques.
- Experience with clinical data development, validation, and documentation.
- Knowledge of FDA 21 CFR Part 11, EDC, and Clinical Data Management systems.
- Understanding of clinical studies; biomarker data experience is preferred.