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