Senior Manager, Clinical Database and Reporting; m​/f​/d

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to 'be an innovative global healthcare company contributing to the sustainable development of society', we are shaping a healthier, more hopeful future for patients, their families, and society.

The Associate Director, Clinical Database Applications and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert responsible for setting the overall programming strategy including the oversight, guidance, implementation, and management of clinical database applications and reporting. The responsibilities include advancing operational excellence by standardizing reporting, scaling programming strategies, automating workflows, and delivering high-quality outputs that meet user requirements by collaborating with a variety of internal and external stakeholders including leading all aspects of end-to-end programming efforts.

In addition, managing quality of data validation programming deliverables, maintaining compliance and inspection readiness of clinical applications, reports, and supporting process documentation, and reporting processes are some of the key requirements of the role. This position provides expertise within Data Management by partnering with internal and external stakeholders (e.g. DM Portfolio Delivery, Data Acquisition & Processing, Precision Medicine, CROs, External Vendors, etc.)

to optimize data programming services on behalf of Daiichi Sankyo. In addition, excellent verbal and written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are some of the requirements of this role. This position requires skills in working in a fast-paced environment, continuous improvement, project management, and change and risk management.

Leadership, Direction, and Strategy:

• Establish programming strategy in designing, developing, and maintaining reporting business needs, including programming capabilities assessment, technology and infrastructure requirements of new and/or existing clinical database applications and reporting solutions
• Act as a subject matter expert in advanced clinical data programming, data transformation, visualization, and emerging technologies to elevate and modernize internal reporting capabilities
• Provide operational leadership and management of clinical database applications and reporting solutions to address business needs consistent with regulatory requirements including GxP, 21 CFR Part 11, data protection and privacy requirements
• Ensure programming-related technical and end-user support to other areas of Data Acquisition & Processing for the development of reports, data listings, and data visualizations consistent with study requirements and integrated data review plans
• Manage direct reports including the development, coaching, and mentoring of team members

Project Management:

• Drive successful delivery of clinical data management programming objectives by aligning priorities, streamlining workflows, and optimizing resources in collaboration with cross-functional stakeholders
• Ensure effective quality oversight of the core clinical database applications and reporting, supporting processes, technology, and infrastructure improvements; maintain audit and inspection readiness of all deliverables
• Oversee the quality of data listings, reports, patient profiles, and metrics, ensuring high-quality, timely outputs that support operational insights in line with integrated data review plans
• Manage and maintain a standard library of data listings and reporting objects to maximize reuse, efficiency, productivity, and standardization
• Manage data exchange agreements and deliver quality data extracts for internal and external stakeholder consumption, compliant with regulatory, data…