Associate Director, Clinical Database and Reporting

Job 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 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 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.

• 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.

• 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.

• 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…