Senior Developer, Clinical Data Reporting

Overview

The Senior Reports Developer will be responsible for effectively supporting the Global Development Data Management organization by creating and maintaining a global library of standard data management reports, listings, metrics, and graphs to drive data quality and support data management oversight activities. The Senior Reports Developer will support clinical study teams to use defined standard DM reports on different platforms including but not limited to JReview, Business Objects, SAS and Spotfire.

Responsibilities

• Translate clinical study teams reporting needs into specifications and provide custom data review reports solutions such as:
• Standard programs for patient profiles
• Reconciliation programs
• Standard and ad-hoc reports for data review to support the clinical teams
• Develop, test, deploy and maintain global standard data review reports on selected platform (JReview, SpotFire, SAS etc) to include Integrated data, CRF data, eCOA and biomarker data)
• Update metadata definitions and specifications in an MDR system
• Collaborate with training team to deliver custom role based training to end users
• May generate reports for end users and multitask based on business deliverables
• Contribute to functional SOPs, Working Procedures and other internal documents
• Provide innovative solutions to generate metrics reports that meet business requirements
• May create compliance reports to confirm standards compliance

Qualifications

• B.S. degree – Major/ Minor (Biology, Computer Science, programming, data management, scientific or analytic discipline or equivalent) with experience with programming and strong knowledge of database structures.
• 5-8 years of data management experience in the pharmaceutical industry
• 5 years of experience with various reporting and analytic tools – JReview, Spotfire, Tableau, Qlik, SAS, and SQL.
• End to end knowledge of drug development process
• Understanding of FDA/ICH guidelines for clinical study data
• Ability to collaborate and work effectively in a dynamic environment with cross-functional stakeholders such as scientists, operational leads, study physicians, data managers and external data providers
• Strong organizational and communication skills in a matrix environment including strong
• attention to detail with a focus on delivering high quality results.
• Knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials
• Strong analytical and problem-solving
• Proficiency in SQL and scripting with experience in developing advanced queries, stored procedures, and views. JReview, Spotfire and SAS programming is a plus.
• Working knowledge of drug development, FDA & ICC/GCP regulations
• EDC build (Rave) experience is a plus

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.