Note: The job is a remote job and is open to candidates in USA. Bits AS is a company seeking a Senior Data Management and Data Quality Analyst to support FDA OCS tools and enterprise platforms. The role leads study data acquisition, validation, loading, curation, regulatory data quality activities, CDISC standards implementation, data governance, reporting, and coordination with clinical and nonclinical services.
Responsibilities
- Perform study data acquisition, validation, loading, and curation
- Validate SDTM, ADaM, SEND, and ISS datasets
- Support DataFit validation and study data quality reviews
- Develop Data Quality Reports and dashboards
- Implement FDA Business Rules and validation rules
- Support Data Governance activities
- Perform root cause analysis of study data issues
- Coordinate with OCS Clinical and Nonclinical Services
- Maintain SOPs and operational documentation
- Support BIMO, Site Selection Tool, Data Central, SEND Explorer, and Study Data Platform
Skills
- Bachelor's or Master's degree in Computer Science, Life Sciences, Biostatistics, or related discipline
- 8+ years of FDA/CDISC data management experience
- Expertise in SDTM, ADaM, SEND, ISS, Pinnacle 21, SAS, SQL
- Experience supporting FDA regulatory review programs
Benefits
- Remote work
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