Principal RWE Research Analyst

Role Overview: You will provide expert support and functional and technical knowledge to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. You will participate in the full lifecycle of producing key data and/or reports, including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities, and provide quantitative analytical support. Additionally, you will provide statistical support for regulatory submissions, planning, analysis, and reporting of clinical safety and efficacy summaries. You may also provide statistical support to research or other R&D areas. Your responsibilities will include advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. You will provide expert support and stellar customer focus to business users and teams on their use of data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations), data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. Key Responsibilities: - Drive the implementation of data analytics reports and dashboards for optimal data review by working with 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 the 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 - Lead and contribute to Clinical Data Standards definition, development, validation, and support within assigned standards discipline (domain) - Define and deliver robust, priority-driven standards development plans for the assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized - Drive the efficient, high quality, and timely implementation of new standards and/or updates to standards for data acquisition and tabulation standards and/or analysis and reporting data standards - Support the translation of scientific and analytical requirements into efficient, compliant standards - Ensure appropriate governance and approval of global and project/study specific clinical data standards - 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 Qualifications Required: - Work experience in Operations Management and Execution, Cross-Cultural Experience, Managing Crises, and Functional Breadth,