Senior Data Management and Data Quality Analyst

The Senior Data Management and Data Quality Analyst leads study data acquisition, validation, loading, curation, and regulatory data quality activities supporting FDA OCS tools and enterprise platforms. The individual provides expertise in CDISC standards, FDA study data guidance, business rules, and data governance. Primary 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.

• 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.

$145,000 - $150,000 a year - Full-time