General Summary

Specific Duties and Responsibilities

• Collaborate with clinical project team to clarify and finalize user requirement specifications for clinical data analysis tools and reports. Communicate with selected vendors and/or build reports and / or tools to meet clinical user requirements. *
• Lead technical projects like the specification, programming and testing of risk-based monitoring reports, complex cross-form data cleaning reports, and integrations between systems. *
• Contribute to the development and maintenance of the data warehouse used to manage libraries of clinical study data including image, source document, and data files.
• Develop dashboards and reports to support the clinical study team by choosing the right programming technique and software tool for each problem. *
• Independently program reports to execute trial-specific data review/cleaning plans
• Design, write, and maintain code to perform complex data transformations, including data import/export, transposition, and ETL processes; ensure accuracy, efficiency, and reproducibility. *
• Integrate data from multiple systems to create reports and dashboards that meet the clinical study needs.
• Automate routine data processing and reporting tasks to improve efficiency and reduce manual effort
• Write, validate, and optimize analytical programming scripts and report specifications
• Assist in the setup of programming timelines and deliverables for projects as required.
• Assist in addressing external application vendor issues, integrations, and implementations.
• Provide support for implementation of upgrades and new modules of remotely hosted vendors, acquiring all necessary documentation.
• Apply programming techniques to improve efficiency, scalability, and quality of data processes, including evaluating alternative coding approaches and tools

• Partner with organizational stakeholders to create and implement data analytics best practices
• Contribute to the build and testing of clinical study databases, by defining study requirements specifications for data validations with minimal supervision and accurately conducting testing of the data validations. *
• Participate in and contribute to project discussions. Communicate with team members on a regular basis.
• Utilize reports and data collection technology to identify possible data errors and questionable data trends
• Participate in audits as required.
• Provide support to senior and manager-level clinical data analysts as needed.
• Mentor and support less experienced clinical data analyst staff, peers, and other department staff. *
• Proactively provide process improvement feedback to management and provide input in SOP and standards updates/development.
• Maintain and continue to gain a broad overall knowledge in the field of clinical data analysis and clinical data management.
• Responsible for attending training classes and professional meetings as required.
• Create training materials for clinical users and developers
• Document data processes and workflows to support reproducibility
• Create analytical data models and tools to help empower clinical teams
• Follow data standards policies, procedures, practices, and regulations for clinical data analysis reports and tools throughout the process of collection and submission of clinical data.
• Further programming and reporting skills independently
• Provide technical support and training on reports and tools for clinical staff.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

• Indicates an essential function of the role

Required Qualifications

• Bachelor's degree in mathematics, computer science, economics, life science, or related field with 2+ years of experience, or equivalent combination of education and experience
• Solid hands-on knowledge of at least one programming language (e.g., Python, SAS, R, MATLAB, C Sharp, Visual Basic, SQL) required

Preferred Qualifications:

• Master’s degree preferred
• Experience in the analysis of medical or scientific data is strongly preferred