SAS SDTM Datawarehouse Analyst

• Actively participates in the development of common data standards and ensures datasets are formatted to comply with the standards, as well as with associated protocol requirements. Ensures that the team utilizes standards
• Ensures that the requirements of each study protocol are reflected in the aggregation of data, in the conformance of data, in the data quality checks, and the use of common data standards. Ensures that Therapeutic Area (TA)- and program-level consistency is achieved
• Establishes and maintains methodology used by the team to conform and curate data, benchmarking against industry standards. Ensures that study data are optimally standardized and analysis ready
• Supports data reporting, analysis and regulatory submissions by aggregating clinical trial data from multiple sources to a centralized data warehouses, and for transforming those data to industry standard formats (e.g., SDTM, reporting). Effectively utilizes advanced technology to execute assigned activities
• Accountable for the on-time design and delivery of fit-for-purpose datasets. Utilizes project management tools to track study progress and plan work. For assigned programs and studies, as well those assigned to team members, anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product owned by self and team is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (Google Cloud Platforms), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring members of the team, as well as contributes to their skill development
• Leads DSS and cross-functional innovation and process improvement initiatives

Qualifications :

• Bachelor s degree in management information systems, computer science, life sciences or equivalent. Master s preferred.
• Must have 5+ years of experience with clinical database design, data loading, and database modeling concepts or 7+ years of experience in a similar technical or clinical development environment.
• Demonstrated intermediate SAS and/or SQL programming skills and expert knowledge of database concepts.
• In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes Demonstrated ability to influence others without direct authority.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to successfully coach/mentor in a matrix environment Demonstrated effective communication skills Demonstrated effective analytical skills

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