Job Description

Summary -Responsible to support all statistical programming/data review reporting and analytics development aspects of assigned studies or project-level activities.

Major accountabilities:

• 1.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. Facilitate interaction with end-user on creating specifications and working with programmers or performing the programming activities for successful delivery
• 4. To provide quantitative analytical support to the global program teams, including providing support on analyzing reports
• 5. Support the planning, execution and close-out of Clinical Programs/Trials.
• 6. Support the management in collation and delivery of analytics reports for critical decision making
• 7. Create, file and maintain appropriate documentation
• 8. Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program/trial operational data
• 9. Provide necessary training to end-user on best / appropriate and consistent use of various data review tools
• 10. Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R
• 11. Good understanding of Novartis Clinical Data Standards and its implementation for creation of reports specifications or reports output

Key performance indicators:

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

Minimum Requirements:
Work Experience:

• 2-5 years of 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:
• 2. Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R)
• 3. Knowledge of Data Review and/or Business Intelligence tools (such as Spotfire, JReview)
• 4. Understanding of clinical data management systems and/or relational databases as applied to clinical trials
• 5. Attention to detail, quality, time management and customer focus
• 6. Ability to translate technical concepts for nontechnical users in the areas of clinical database design and data review reporting development
• 7. Strong verbal and written communication skills to work with our global partners and customers
• 8. Understanding of Drug Development Process, ICHGCP, CDISC standards and Health Authority guidelines and regulation

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