Sr. IT Business Analyst, R&D

Role Summary

Sr. IT Business Analyst, R&D supporting the Clinical Operations organization within a biopharmaceutical environment. Responsible for leading data integration efforts, translating business requirements into data analytic solutions, and maintaining SOPs and data management practices. Serves as point of contact for the SAS platform and collaborates with IT and vendor teams in a fast-paced, growth-focused setting. Based in Lexington with a hybrid schedule.

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‚Äôs with 8+ years‚Äô experience working in IT and applications experience within the biotechnology/pharmaceutical industry supporting both clinical and SAS applications; Master‚Äôs Degree Preferred
• 2+ years of experience working with Tableau and solid understanding of how reports are consumed
• 3+ years‚Äô 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

Skills

• Data integration and analytics
• Clinical data management
• Vendor management
• SAS, Tableau, and data visualization
• Data mapping and Snowflake
• UAT coordination and test script development
• SOP creation and maintenance
• Strong communication and collaboration across IT and Clinical Operations

Education

• Bachelor‚Äôs degree required; Master‚Äôs degree preferred

Additional Requirements

• Hybrid work arrangement: 4 days in office, 1 day remote