Sr. IT Business Analyst, R&D

Role Summary

Sr. IT Business Analyst, R&D will support the development and implementation of technology initiatives and IT solutions for the Clinical Operations organization, with a focus on data integration, analytics, and SAS platform support. Based in Lexington with a hybrid schedule of 4 days in the office and 1 day remote. The role requires collaborating with Clinical Operations and the data engineering team to translate business requirements into data analytic solutions and to create and update SOPs, standardize data management practices, and lead multiple concurrent initiatives in a dynamic, growth-focused environment.

Responsibilities

• Manage day-to-day support for the Clinical Development Data Pipeline platform
• Complete all necessary system documentation and other required documentation needs
• Support all new clinical studies ensuring that the CRO data files are implemented accurately within CDDP
• Standardize clinical study data import formats for CDDP
• Define and document new clinical study set up workflows and steps
• Analyze current processes to gather requirements, identify gaps, and recommend improvements to better leverage technology
• Facilitate and lead business process and design sessions to define functional and technical requirements
• Collaborate with project leadership to identify risks, develop mitigation strategies, and manage scope effectively
• Oversee development activities, assist with test script creation, coordinate User Acceptance Testing (UAT), and support implementation of updates tasks related to data analytics and other platforms
• Develop and implement data management processes that optimize data platforms, ensure secure and efficient data retrieval, and comply with organizational policies
• Ensure changes in source systems are accurately reflected in analytical reporting and integration points
• Identify training needs and partner internally to develop and deliver user education (e.g., Veeva eTMF, SAS, Tableau)
• Create and maintain SOPs and work instructions to ensure IT processes remain current and standardized
• Collaborate with IT colleagues to ensure end-user support systems effectively meet the needs of Clinical Operations
• Proactively communicate system changes and updates to stakeholders in a timely manner

Qualifications

• A bachelor’s with 8+ years’ experience working in IT and applications experience within the biotechnology/pharmaceutical industry supporting both clinical and SAS applications; Master’s Degree Preferred
• 2+ years of experience working with Tableau and solid understanding of how reports are consumed
• 3+ years’ experience working on data analytics and data mapping in Snowflake
• eTMF experience preferred
• SAS knowledge is a plus
• Strong familiarity with cloud database platforms with solid understanding of SQL (Snowflake preferred)
• Strong familiarity with source systems (e.g., EDC, IRT, CTMS, eCOA) and how data is sourced and stored
• Experience leading projects with multiple stakeholders (e.g., Clinical and Biometrics)
• Experience in managing vendors supporting and enhancing Clinical Development
• Excellent project management skills, including the ability to lead in an environment with multiple partners, vendors and contending priorities
• Compliance with all laws, regulations, policies, and procedures that govern the conduct of Kiniksa activities