Standards Developer

The Standards Developer I is primarily responsible for providing support to deliver study metadata for data collection

components using cloud-based platform (Clinical Metadata Repository - ryze), leveraging the existing Clinical Data

Standards, for assigned clinical projects. Can provide solutions for study specific data collection metadata whilst adhering to

industry and company standards methodology. Liaises with variety of departments on a local and/or Global level to ensures

delivery of data collection standards. May work under direction of a Senior or Principal Standards Developer.

Typical Accountabilities

• Under supervision, develops and maintains study metadata for data collection using cloud-based platform (Clinical Metadata Repository)
• Monitors, develops and updates study metadata within defined system
• Leads quality of own deliverables and completeness of applicable quality and process documentation
• Can contribute to the development of best practices to develop, maintain and publish study metadata consistently
• Collaborates with other Standards Developers as well as Study Team members at study level (i.e. Data Management and Programmers)
• Seeks or continues to acquire knowledge of Data Collection Standards development and Study setup processes
• Takes steps to understand the roles and skills of other functions in drug development
• Can contribute to function by training and mentoring

Essential

• BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.
• Knowledge of MS Excel, deep attention to details and systematic approach to work
• Good communication skills in both written and spoken English
• Good collaboration skills

Desirable

• Knowledge of the existence of industry standards (eg, CDASH, SDTM, ADaM)
• Experience with clinical data standards (eg, in Data Management, Programming, Statistics)
• Ability to understand and adhere to business processes Intermediate standard development skills (eg, raw data standards with data collection and cleaning components)
• Knowledge of industry standards (eg, CDASH, SDTM, ADaM Understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS,