The Laboratory Standards Analyst role is a key role in the newly chartered Data Exchange group within Data Management Sciences. This role will support the group's core responsibility to ensure data received by BioMarin, from an outside source, is fit-for-purpose for all downstream activities by conforming with defined standards, specifications, and exchange requirements.
Responsibilities
Communicate with cross functional teams and vendors to elicit study requirements and design considerations related to data specifications development.
Review / interpret study documentation to develop data specifications / standards for data transported to BioMarin from an outside source.
Define and develop and/or procure specifications, code lists, and dictionaries for new studies.
Compile specifications and study requirements to develop Data Transfer Specification documents.
Assess study design changes and vendor document updates to identify required updates to specifications, code lists, and dictionaries.
Identify changes to controlled terminology for ongoing studies.
Review conformance findings, identify root cause, communicate to appropriate person or vendor for resolution.
Adhere to study timelines; communicate risk, issues.
Proactively identify and resolve/escalate project-related operational issues.
Support creation and expansion of controlled terminology global library.
Collaborate on creation and expansion of conformance check global library.
Work to become subject matter expert for data conformance processes and technology platforms.
Identify controlled terminology updates, incorporate update relevant global libraries.
Provide input to Data Exchange team to support process development or improvements.
Provide input to creation of Data Exchange Standard Operation Procedures and Work Instructions.
Minimum Qualifications
Bachelor's degree or equivalent combination of education/experience in STEM-related field.
Basic understanding of clinical trials, ICH, GCP, 21CFR Part 11 compliance, GCDMP.
At least 2 years demonstrated applied knowledge with one or more of the following: SDTM / CDASH / CDISC.
Experience developing or actioning data transfer agreements, i.e., laboratory, eCOA, etc.
Ability to build relationships within the team, across departments, and with external contacts.
Comfortable working independently on routine assignments.
General understanding of data workflow methods and tools.
Basic understanding or experience developing or interpreting technical programming specifications.
Working knowledge of system validation and user acceptance testing workflow.
Preferred Qualifications
Demonstrated proficiency, competency and understanding of fundamental principles of clinical laboratory procedures or clinical expertise to understand assay technical documentation.
At least two years working in operational role in clinical research, i.e., data manager, CRA, data analyst etc.
Demonstrated working understanding of clinical trials, ICH, GCP, 21CFR Part 11 compliance.
Working knowledge of standards library platforms such as Formedix, Pinnacle 21 Data Exchange or equivalent.
Experience using Spotfire or similar dashboarding platforms as an end-user or developer.
Working knowledge of one or more of the following languages: SAS, R, SQL, Python.
Holds certification, license, or degree as one of the following: MD, PA, Medical Technologist, RN.
Seniority level
Entry level
Employment type
Full-time
Job function
Information Technology
Industries
Information Technology & Services
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