Senior Database Developer, Data Management Science

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

Data Management Science Group

The Data Management Science group contributes to Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The Database Development sub-function is responsible for the efficient and effective database development and clinical programming in support of delivering complete, correct, and consistently fit-for-purpose data sets for statistical analysis. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of programing and database requirements specification, oversight of database builds, clinical programming for data transfer and validation, and the preparation and approval of data sets for data lock/data snapshot analytical activities.

Responsibilities

• Review eCRF Requirements, Edit Check Specifications, and EDC Change Requests for any database development activities
• Conduct the clinical database development for eCRFs, edit checks, matrices, dynamics, and integration objects, as required per specifications
• Conduct the programming and testing of Data Validation Checks (DVC) Level 1 checks (edit checks in EDC)
• Conduct Peer Review on clinical database development objects
• Conduct the clinical database development mid-study changes, testing activities, and production implementation
• Create database development documentation with the Data Managers

Education

MS degree (preferred) or BA/BS degree with a focus in statistics, computer science, life science, or related scientific discipline.

Experience

2+ years of experience in clinical development, including technical experience within and outside of Data Management, with MS; 5+ years with BA/BS.

• Gathers data and input, using multiple sources if applicable, to develop holistic understanding of problems
• Seeks opportunities to interact with peers and stakeholders; builds a network of internal and external peers
• Demonstrates resourcefulness to find, and resolve to be comprehensive in obtaining, information needed for complete and timely closeout of tasks
• Emerging understanding of team roles and responsibilities and how they contribute to overall priorities; recognizes opportunities to attract talent to the organization
• Responds promptly to stakeholders, peers, and management with clear and organized messages and ensures that important information is shared in a timely manner
• Exhibits a focus on performance measurement to track progress toward objectives
• Understands basic data validation plans, data quality checking processes, and impact on data sources; identifies and escalates data inconsistencies and errors appropriately
• Demonstrates a basic familiarity with database design and database architecture concepts
• Demonstrates basic understanding of how programming supports study execution phases; ask questions and seeks guidance to clarify understanding and priorities
• Demonstrates a familiarity with MedDRA, WhoDD, and other dictionaries, purpose and uses for coding terms

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.