| || 228749BR |
| || Data Analytics and Review Specialist |
| || NIBR |
| || Oncology NIBR |
| || China |
| || Shanghai |
| || China Novartis Institutes for BioMedical Research Co., Ltd |
| || Research & Development |
| || Full Time |
| || Regular |
| || You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV. |
| || Job Purpose
Responsible for all clinical data review aspects of 3-5 Translational Clinical Oncology projects. The position is a co-leader with clinical operation in ensuring the planning, execution and close-out of the clinical trials in Translational Clinical Oncology (TCO) are efficiently with timely and high quality.
1. Responsible for clinical data review activities as groups of projects in Translational Clinical Oncology, implement clinical data review strategy for the project(s) together with the Clinical Operations.
2. Act as SME for the existing data review tools, JReview and Spotfire.
3. Provide recommendations as representative of the clinical data review function at project level.
4. Translate TCO clinical questions into analytical problems and build solutions utilizing data visualization tools.
5. Build and maintain effective working relationship with cross-functional team, including DO, Bios and clinical counterparts, able to summarize and discuss status of deliverables.
6. Negotiate and prioritize the assignments on the projects for clinical data review deliverables.
7. Provide guidance to the internal and external (CRO, FSP) programmers assigned to the projects on TCO expertise and company process.
8. Comply with company standards and processes, ensuring clinical data review innovations and foster clinical data review solutions, ensure their efficient implementations and knowledge sharing within TCO.
9. Responsible for quality control and audit readiness of all assigned clinical data review deliverables as well as accuracy and reliability of the results.
10. Ensure the standardization from CRF, CCG, statistical analysis plan, to data review plan for assigned projects.
| || Education: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences, data management or related field
Languages: Fluent English (oral and written)
• Proficient SAS experience and proven skills in the use of SAS within a programming environment to develop and validate deliverables, proven experience in development of advanced MACROs
• Expert experience in contributing to data review plan and statistical analysis plans and/or constructing technical programming specifications
• Proven communications and negotiation skills, ability to work well with others globally
• Experience in JReview, Patient Profile, Sptofile, R programming or other data visualization tools
• Lead several studies, project-level activities, preferably in Oncology
• Ideally 5+ years industry experience in statistical programming or data management