Manager, Data Validation and Reporting

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Manager, Data Validation & Reporting

Job Summary

The Manager, Data Validation & Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Process, and technology. Accountable for the quality and delivery of the Data Management programming, reporting and visualization, standard, and exception data listings across studies. Scope of work includes oversight and expertise in the design, development, and validation of programs, standard and adhoc reports, standard and exception data listings, and visualizations to support ongoing data review activities, achieve critical study milestones, and gain data insights into our clinical studies. The position requires good understanding of programming methods and techniques, critical thinking, and complex problem-solving skills. This position will require strong collaboration in working with other members of the Biostatistics and Data Management, external CRO partners, and other stakeholders.

Responsibilities

1. Serve as a subject matter expert and provide expertise for Database programming, Reporting, and Technology and optimize the use of Spotfire, JReview, ETL, SAS tools, and others to support business needs.

• Manage the quality of the data management clinical database programming deliverables including edit checks programming, complex reports, and listings; patient profiles, subject narratives, exception listings, dose modification reports, and other adhoc reports as part of standard data validation and reporting package for clinical studies.
• Develop and/or provide oversight on the programming specifications for the data validation and reporting deliverables; code, test, and document deliverables conforming to programming standards, data quality and governance, and validation policies.
• Partner with internal and external stakeholders to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of visualization tools.
• Develop programming specifications and guide the implementation of programs to facilitate in data reconciliation efforts.

2 Develop standard programs, templates, reports, data listings, discrepancy reports, and patient profiles to facilitate in the ongoing review of clinical data during study conduct and study closeout.

• Build, test, and scale-up programs for data validation derivation procedures, data reports, listings, and SAS on Demand relational database extracts for operational use, identification of data outliers, quality inconsistencies, and preparation for analysis.
• Provide technical guidance and direct programming tasks for Medical Coding activities.
• Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including interim analysis, and database lock activities.

3. Perform ETL tasks, enhancements, validation, and maintenance of the programs and templates on an ongoing basis.

• Perform QC, lead unit testing activities, develop validation scripts for user acceptance, manage and execute programs and dry runs as needed, and resolve programming issues proactively.

4. Develop and maintain mapping, and program specifications for standard reports, listings, and visualizations.

• Maintain database programming checklists and trackers to ensure conformance of high-quality deliverables with the study data validation and reporting package.
• Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.

5. Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.

Qualifications:

Education

• BA/BS degree required, MS or equivalent degree preferable.

Experience

• Minimum of 5 years database programming experience and data validation programming in the device/pharmaceutical/CRO industry
• Expertise in Clinical Programming, methods, and techniques
• Expertise in using standard reporting and data visualization tools including Spotfire, JReview, and SAS tools
• Knowledge of industry standard clinical technologies including CTMS, EDC (RAVE, InForm)
• Knowledge of CDISC data standards
• Knowledge and understanding of relational databases

Competencies

• Clinical Programming, Project Management, and Technical Expertise
• Knowledge of logical data design and data mapping
• Knowledge of reporting and data visualization tools: Spotfire, JReview, SAS suite and ETL technology
• Experience with programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.
• Proficient in industry standards, medical terminology, and clinical trial methodologies.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.