Job Description

Summary Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. These tasks are to be performed independently or team based with minimal guidance and supervision.

Major accountabilities:

• Produce and track reports for various line functions within Global Drug Development, used for ongoing monitoring of clinical data
• 2. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders
• 3. Author /co-author the user requirements document, functional specifications and functional testing scripts
• 4. Facilitate interaction with end-user on creating specifications and working with programmers or performing the programming activities for successful delivery.
• 5. To provide quantitative analytical support to the global program teams, including providing support on analyzing reports
• 6. Support the planning, execution and close-out of Clinical Programs/Trials.
• 7. Support the management in collation and delivery of analytics reports for critical decision making
• 8. Create, file and maintain appropriate documentation
• 9. Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program/trial operational data
• 10. Provide necessary training to end-user on best / appropriate and consistent use of various data review tools
• 11. Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R.
• 12. Good Knowledge of Novartis Clinical Data Standards and its implementation for creation of reports specifications or reports output
• 13. Support special projects of limited scope (sub team lead, local project, etc.) both clinical and non-clinical in nature.
• 14. Provide study level expertise and involvement in CTTs.
• 15. Lead or provide support to special projects both clinical and non-clinical in nature or in general areas spanning various responsibilities but not limited to systems issues, processes, user support, training, etc

Key performance indicators:

• 1. Quality and timeliness of deliverables
• 2. Revisions to deliverables caused by logic or programming errors
• 3. Customer feedback and satisfaction

Minimum Requirements:
Work Experience:

• At least 5-7 years' experience in clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry as well as the following:
• o Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R)
• o Strong knowledge of Data Review and/or Business Intelligence tools (such as Spotfire, JReview)
• o Knowledge of clinical data management systems and/or relational databases (e.g. OC/RDC, INFORM, RAVE) as applied to clinical trials
• o Attention to detail, quality, time management and customer focus
• o Ability to translate technical concepts for nontechnical users in the areas of clinical database design and data review reporting development
• o Strong verbal and written communication skills to work with our global partners and customers
• o Understanding of Drug Development Process, ICHGCP, CDISC standards and Health Authority guidelines and regulations
• o Ability to train and supervise new or less experienced associates.

Skills Desired Clinical Trials, Computer Programming, Data Analysis, Programming Languages, Reporting, Statistical Analysis