Lead Clinical data science programmer

The Lead Clinical Data Science Programmer 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:
o Standard programs for patient profiles
o Reconciliation programs
o 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

• 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 skills.
• 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

• 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.

EXPERIENCE
• 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