Senior Developer, Clinical Data Reporting

March 19

Apply Now

Receive Emails with Similar Jobs

ICON plc

WebsiteLinkedInAll Job Openings

ICON plc is a leading Contract Research Organization (CRO) that provides comprehensive clinical, consulting, and commercial services to the biopharmaceutical industry. With a focus on innovative solutions, ICON supports the development of transformative therapies by offering a range of services including clinical trials, regulatory affairs, and market access strategies. The company is dedicated to advancing drug development through its global expertise and cutting-edge technology.

Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes

10,000+ employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• 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. • 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.

🎯 Requirements

• 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

🏖️ Benefits

• 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