-Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. 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. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines.

Major accountabilities:

•Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic.

•Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate.

•Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner.

•Provide coordination between the project resources so that deadlines are met on deliverables.

•Drive development of appropriate user training.

•Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization.

•Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

•Timely execution of of projects & data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs

Minimum Requirements:

Work Experience:

•Functional Breadth.

•Cross Cultural Experience.

•Managing Crises.

•Collaborating across boundaries.

•Operations Management and Execution.

Skills:

•Automation.

•Biostatistics.

•Clinical Trials.

•Computer Programming.

•Metadata Management.

•Statistical Analysis.

Languages :

•English.

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Statistical Analysis

Computer Programming

Biostatistics

Metadata Management

Automation

Clinical Trials