Manager, Data Programming, Analytics & Reporting

Job Summary

The Manager, Data Programming, Analytics, and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Data Visualizations, and supporting programming tools. This position will manage the accountability for the quality and delivery of Programming deliverables consistent with business needs of each study team conforming to programming standards and specifications across clinical studies. 

The 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 using SAS or visualization software such as Spotfire or JReview 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, service providers, and other stakeholders.

Responsibilities

Leadership, Direction and Strategy:

• Manages accountability for the quality and timely delivery of the Data Management Programming, Reporting, visualizations, and data listings across clinical studies.
• Mentors and trains Data Validation and Reporting Specialists as needed.
• Contributes to the development of Standard Operating Procedures (SOPs), policies, and guidelines.
• Provides insights and/or recommendations to streamline data management information flow, enhance business efficiencies, and improve quality.
• Provides training on the data visualization software as required.
• Is accountable for Clinical study data programming deliverables meeting quality and time expectations for assigned studies.
• Proactively identifies and manages risks to data quality, data integrity, and timelines with respect to regulatory submissions.
• Builds business relationships with other line functions; is an ambassador and Programming SME.
• Provides information pertaining to programming for audits and regulatory inspections.
• Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners.

Project Management:

• Manages the quality and delivery of the Clinical study data programming deliverables for assigned studies 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.
• Provides 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.
• Partners with the study data managers to develop and confirm programming specifications, support adhoc external data reporting and listings needs, and manage quality expectations in collaboration with internal and external stakeholders.
• Proactively identifies and resolves issues that may influence and/or impact study quality and other deliverables.
• Manages and mitigates quality and delivery risks to ensure adherence to timelines, and quality thresholds.
• Is accountable for inspection readiness of Programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory requirements.

Qualifications

Bachelor' s Degree Required.  Master's Degree preferred.

Minimum of 5 years of Global Clinical Trial Experience in the device/pharmaceutical/CRO industry; expertise in Clinical Programming, methods, and techniques; expertise in the use of standard reporting and data visualization tools including Spotfire, Tableau, JReview and SAS tools; knowledge of CDISC and CDASH standards; knowledge and understanding of industry standard clinical technologies including EDC, CTMS, and IRT. Required

Additional Skill:

• Expertise in Clinical Programming, methods, and techniques
• Work collaboratively with people at different levels of experience, different disciplines, and cultures
• Self-directed; able to work independently
• Critical thinking and complex problem-solving skills
• Ability to manage multiple priorities
• Strong background in programming development, project management, validation, execution, maintenance, documentation, and archival of clinical data
• Knowledge:
• Expertise in supporting and handling external data; viewing and integrating data in multiple formats including SAS
• Proficient in industry standards, medical terminology, and clinical trial methodologies
• Experience with industry standard reporting and data visualization tools
• Experience with one or more industry standard clinical technologies such as CTMS, EDC (RAVE, InForm), Veeva Vault, IRT, and Clinical Portals
• Knowledge and understanding of data standards - CDASH, SDTM/ADaM, CDISC
• Knowledge and understanding of relational databases