Principal RWE Research Analyst

Novartis India


Date: 3 weeks ago
City: Hyderabad, Telangana
Contract type: Full time
Summary

  • 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 and 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.

About The Role

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.
  • Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.
  • CDS Role 1.
  • Lead and contribute to Clinical Data Standards definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.
  •  2.
  • Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
  • 3.
  • Responsible for driving the efficient, high quality and timely implementation of new standards and/or updates to standards for:a.
  • Data Acquisition and Tabulation standards Or/and; b.
  • Analysis and Reporting Data Standards4.
  • In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards.
  • 5.
  • Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
  • 6.
  • Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis & implementation of action plans where needed.
  • 7.
  • Communicate an

Key performance indicators:

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

Minimum Requirements:

Work Experience

  • Operations Management and Execution.
  • Cross Cultural Experience.
  • Managing Crises.
  • Functional Breadth.
  • Collaborating across boundaries.

Skills:

  • NA.

Languages :

  • English.

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Analyst

Solenis, Hyderabad, Telangana
4 days ago
Primary Role – (overview And Overall Purpose Of Job)This position will be part of the Global Analytics Hub. Leverage data analytics and data mining skills to deliver insights for the commercial organization that drive revenue increase, profitability improvement and margin expansion globally. Reporting to Analytics Associate Manager, the analyst will be responsible and accountable for all quantitative analysis in the...

Sr Python Gen AI Engineer

Verisk, Hyderabad, Telangana
4 days ago
Job DescriptionThis person has successfully developed data and analytics solutions and understands best practices in data modeling, data engineering and AI Products. To be successful the candidate needs to thrive in a highly collaborative, cross-functional teams’ environment. This position offers excellent future growth opportunities along either technology or management tracks. If you are an experienced python engineer, who enjoys solving...

Controllers - Regulatory Reporting - Vice President - Hyderabad

Goldman Sachs, Hyderabad, Telangana
4 days ago
Job DescriptionCONTROLLERSControllers ensure that the firm meets all the financial control and reporting obligations of a global, regulated, and public financial institution. Our professionals measure the profitability of, and risks associated with, every aspect of the firm's business. Controllers also ensure that the firm's activities are conducted in compliance with the regulations governing transactions in the financial markets.OUR IMPACTWe're a...