Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, elluminate ® Data Programming. This role will drive the programming and processes in elluminate® to support cross functional data review.

Job Duties and Responsibilities

• Assist in development and delivery of a clinical data strategy that allows the organization to be resilient and responsive to changes in the industry such as evolution in data collection methods, novel techniques for working with data, and changing regulatory requirements.
• Produce validated tables, data listings, and custom reports presenting clinical data summaries for inclusion in reports and data review activities managed by the data management department.
• Explore new programming technology; test, document, and integrate software tools into programming procedures.
• Utilize SAS/SQL programming skills to perform all programming required for internal clinical trial analysis and reporting.
• Collaborate with Data Management to test the applications functionality.
• Provide diagnostic support and fix defects as needed.
• Provide programming solutions and support using the elluminate® Data Intelligence Hub platform. Configuration, migration, and support of the elluminate® platform
• Align cross functional team clinical data review objectives to functionality in elluminate® and deliver gap analysis where applicable

• Participate in development of new processes, best practices, and recommend improvements to all procedures to ensure optimal level of cross functional team satisfaction

• Configure elluminate® software to meet the cross functional team requirements
• Participate in elluminate® implementations by providing business process and product best practices consulting services to support the technical and project management team members
• Provide application administration and technical support as the subject matter expert on core business packages related to elluminate.
• Perform elluminate® programming, testing, mapping, data feeds and documentation in accordance with programming standards.
• Assist in developing and implementing data mappings to import into elluminate.
• Program and generate data review tools, such as patient profiles and data listings, to support data review in Data Central and Clinical Data Analytics.
• Works with clinical trial project teams and management to adhere to quality standards and project timelines.

Key Core Competencies

• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing, dynamic company.
• Ability to develop and deliver training materials to achieve team understanding of projects and enable effective delivery.
• Ability to apply extensive programming knowledge and skills
• Ability to implement data validation and data review plans
• Demonstrated proficiency in using systems and technology to achieve work objectives.
• Able to manage competing priorities and encompass company best values.
• Expertise in clinical program indications, end points, dataflow, data integrity, standards, and data quality
• Working Knowledge of ICH, Good Clinical Practice and FDA regulations.
• Extensive knowledge of Base SAS, SAS/STAT, SAS macros, and EDC.