A member of the CDISC Data Science team, this position leads the development and testing of standards metadata content that will become part of the CDISC Library metadata repository. This position develops specifications for the software engineers to create new metadata products for the CDISC Library or other CDISC systems. The Sr. Metadata Analyst supports the Data Science team by leading quality control and supporting its software tools and metadata products. This position participates in the CDISC standards development teams by providing leadership in metadata development.
Reports to: Director, Data Science
Direct Reports: n/a
Key Operational Responsibilities:
- Establishes best practices for a standard development process that is compatible with automated processes to load metadata into CDISC Library and produces metadata that supports standards-driven automation.
- Identifies end-to-end metadata opportunities and influences the development for them.
- Creates specifications for software tools and standards metadata products, including those incorporated into the CDISC Library.
- Participates as a member of the Data Science team by leading the standards metadata reviews, curation, software tool testing, and support.
- Contributes to the definition of new metadata as part of the standards development and curation process. Create and maintain the curation process accordingly.
- Reviews standards metadata deliverables for accuracy and quality.
- Develops expertise in the use of CDISC Library software tools, loads standards metadata into CDISC Library, and provides CDISC Library exports for access by the community.
- Tests new CDISC Library software tools and metadata outputs.
- Writes technical documentation supporting CDISC Library processes and tools.
- Initiates and drives to completion any necessary additions and/or updates to metadata.
- Works with individuals and teams in preparing standards metadata for loading into CDISC Library.
- Follows the CDISC standards development process and all applicable CDISC Operating Procedures (COPs).
- Use best and recommended practices to search for, create and maintain metadata, as needed and available.
- Maintains healthy communication patterns with colleagues and organizations, subject matter experts and technical harmonization experts.
Education and Experience:
- Bachelor’s degree and 7 years of experience with 5 years of hands-on experience working with the CDISC standards.
- Knowledge of CDISC standards (e.g., SDTM, CDASH, ADaM, CT).
- Understands data modeling concepts and/or metadata repository standards.
- Understands clinical development and regulatory data submission processes.
- Experience in metadata-driven automation.
- Experience in testing, testing methodologies, and quality assurance.
- Assist with CDISC Library tooling design and review.
- Knowledge of the various media types and formats used to represent metadata (e.g., XML, CSV, ODM, JSON, RDF)
- Experience working in data bases (e.g., Graph, NoSQL, RDBMS).
- Experience working in a SCRUM agile setting.
- Organized, attentive to detail and able to work under multiple projects and deadlines.
- Self-starter, works independently with minimal amount of supervision.
- Ability to communicate written and verbal information in a clear, professional manner. Able to make formal presentations to senior management and staff.
- Skilled in general computer applications, such as Microsoft Office.
- Agrees to the CDISC Code of Conduct and Intellectual Property policies.
Physical work component:
- Sedentary: lifting no more than 10 pounds at a time and occasionally lifting or carrying articles like docket files, ledgers, and small tools.
- Travel for this position is expected to be 10% or less.
- Please send your resume/CV, cover letter and salary expectations to firstname.lastname@example.org.
- Applications without a complete cover letter including salary expectations cannot be considered.