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Clinical Data EngineerPurpose:
Provide study/standard level technical programming support in collaboration with key stakeholders during setup, conduct and closeout activities. Provide study level support for data structures definitions, monitor quality and standards adherence. Provide study data transformation programming, data loading, data quality checks, data provisioning, and data information flow in the Clinical data environments within a Therapeutic Area or Global Standards Implementation.
Scope:
Global
Key Tasks: Interpret protocol requirements to translate and document them into study level technical specifications.Develop study level programs for setup, conduct and closeout activities in the clinical data environments.Provision clinical study data to business consumers.Perform data loading/exchange activities (including data exchange with CROs and vendors) and ensure compliance against agreed data transfer specifications.Develop solutions based on gathered requirements from consumers to meet immediate and long-term needs of business customers.Monitor and maintain ongoing study level operations of clinical data environments, respond to study issues.Collaborate with study team functional representatives to ensure a sound understanding of the technical platforms for standardized solutions to study related requests or issues.Ensure adherence to program development, validation and maintenance principles to produce high quality data in line with SOPs, OIs and Best Practice Documents for all data models/environments inclusive of supporting ways to define/enable automation and efficient re-usability.Ensure end-to-end data flow process where traceability requirements are met following Bayer Standards.Complete all documentation associated with programming tasks (e.g. validation, report specifications etc.) in compliance with applicable SOPs and IOs.Estimate the time and resources needed to complete assignments.Track work progress and provide status reports to line manager and study team representatives.Key Working Relations:
Standards Management & Quality Assurance, Data/Medical Review Specialists, Data Managers, Medical Coding, Data Acquisition Specialists and Programmers, Technology and Application Management, Statistical Analysts, Statisticians.
Qualification & Competencies: Masters in a natural science, Statistics, Computer Science or a related field with 3 years of experience in a technical environment or equivalent, focusing on data warehousing and/or ETL activities.Bachelors in a natural science, Statistics, Computer Science or a related field with 5 years of experience in a technical environment or equivalent, focusing on data warehousing and/or ETL activities.Knowledge of data warehousing principles, technologies and related ETL processes.Experience with metadata repositories, preferred.Experience with a variety of programming languages including but not limited to PL/SQL, JAVA, SAS, C#.2+ years hands-on experience programming in relational databases: SQL and Oracle PL/SQL, using SQL Developer, TOAD or similar program development applications for realization of automations and programming activities in a regulated environment.Knowledge of clinical data structures (i.e. CDISC standards for CDASH, SDTM and ADaM), preferred.Knowledge of comprehensive software validation activities using different methodologies (i.e. waterfall, agile, etc.), inspections, analyses, and other verification tasks performed at each stage of the software development life cycle.Excellent oral and written communication skills in a global environment.
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