Associate Director, Clinical Database and Reporting

Position: Associate Director, Clinical Database Applications and Reporting
Location: Basking Ridge

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.

Job Summary Summary 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 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 process 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/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, change and risk management.

Job Description Responsibilities 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 the 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 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 protection, and data privacy requirements. Responsibilities Continued Functional Expertise:
Serve as a subject matter expert for the oversight, guidance, implementation, and management of clinical applications and reporting solutions with expertise in Data Management Systems. Support the integration of clinical data from CRF and non-CRF data sources to streamline workflow, improve efficiencies, and quality of data management processes and deliverables. Serve as a trusted SME in clinical data management programming and reporting, leading resolution of complex issues and guiding internal teams and external partners to achieve successful outcomes.

Partner with clinical database programming, external data acquisition & management, study data managers, and external vendors to perform quality checks for…