Sr. IT Business Analyst, R&D en Kiniksa Pharmaceuticals

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative therapies for patients with serious diseases. With a focus on immunology and inflammation, Kiniksa has a growing portfolio of approved and investigational treatments, and operates with a commitment to scientific excellence and patient impact. 

Reporting to the Senior Director of IT, R&D the Sr IT Business Analyst will support the development and implementation of technology initiatives and IT solutions for the Clinical Operations organization.

Collaborating closely with peers focused on Clinical Operations, this individual will lead integration efforts to gather data from relevant vendors and sources by evaluating and analyzing data and defining appropriate data connection strategies. They will partner with the data engineering team to translate business requirements into effective data analytic solutions to clinical operations.

Additionally, the role includes responsibility for creating and updating SOPs, work instructions, and standardizing data management practices.

The candidate will also be the point of contact for the SAS platform to enable effectiveness and productivity of teams in the rapidly changing clinical development world.

The ability to navigate ambiguity is a valuable asset for this role.

The successful candidate will contribute to defining and developing data connection requirements, as well as supporting SAS-related needs. Strong vendor management skills and the ability to execute independently are essential.

This individual will also be expected to lead and manage multiple concurrent initiatives.

Ideal candidates will bring a positive, adaptable, and hands-on approach, thriving in a fast-paced, dynamic environment during a period of significant growth. Independence, flexibility, and collaborative spirit are key to success.

This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

• 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.
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.