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 Position

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.

Roles and 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 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 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 the reconciliation of external data with EDC
• Contribute to the development of standard and custom reports and data listings specifications; develop and evaluate complex listings and reports including patient profiles, dose modification listings, exception listings, medical coding, among others to support critical and time-sensitive study milestones
• Collaborate with the clinical database programming group to create, manage, and maintain validated toolsets, macros, and automated scripts for code optimization and standardization to maximize efficiencies, consistency, and quality of outputs
• Explore novel and automated approaches to data extractions, data wrangling, and contextualizing data assets to develop innovative solutions compliant with regulatory, data protection, and privacy requirements
• Establish appropriate SOPs/SOIs, work procedures/guidance, job aids, and trackers to guide the operational use of custom reports, data listings, and data visualizations for study needs

Operational Efficiency / Continuous Improvement:

• Identify and address areas of gaps and opportunities to enhance and improve operational efficiencies and productivity through automation, code optimization and standardization, process improvements, and improving the quality of actionable insights
• Proactively identify risks and mitigation approaches to overcome impediments and improve operational efficiencies

Personal Skills and Professional Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

• Bachelor's degree or higher in life sciences or a related field required
• Master's degree in life sciences or a related field preferred

Work Experience:

• Minimum of 7 years of global clinical trial experience in the device/pharmaceutical/CRO industry with expertise in clinical database programming, methods, and techniques supporting Clinical Data Management systems and services required
• Skilled in areas of data validation programming, creating complex data listings, reports, and data visualizations; reconciliation of external data; expertise in industry-standard reporting required
• Experience with data visualization tools such as Qlik, Spotfire, Tableau, Power BI, JReview, SAS, Domo, among others required
• Knowledge of CDASH and CDISC data standards; knowledge of data acquisition, aggregation, contextualization, integration tools, and technologies required

Competencies:

• Strong knowledge and techniques of data extraction, data wrangling, exploration, and contextualization of data assets in the clinical domain
• Expertise in data validation programming and analysis proficiency with SAS tools, SQL, and Python/R
• Deep experience working with a variety of industry-standard reporting and data visualization tools for data insights, data listings, and custom reports
• Proficient in industry standards, medical terminology, and clinical trial methodologies
• Knowledge and awareness of industry trends, best practices, and emerging technologies for data collection, management, reporting, and analytics
• Knowledge of industry-standard commercial clinical systems such as EDC, CTMS, IRT, CDR, and eTMF

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.