Salesforce Developer

Oncology Auditing Timelines Leadership Management Governance Innovation Data Quality Data Analysis Biostatistics Collaboration Accountability SAS (Software) Data Integrity Data Reporting Pharmaceuticals Clinical Trials Immune Disorder Data Management Data Validation Critical Thinking Programming Tools Impact Assessment Project Management Influencing Skills Data Visualization Industry Standards Medical Terminology Relational Databases Cardiovascular Disease Regulatory Requirements Complex Problem Solving Sustainable Development Data Visualization Software Standard Operating Procedure Electronic Data Capture (EDC) Milestones (Project Management) Clinical Trial Management Systems Spotfire (Data Analytics Software) Tableau (Business Intelligence Software), 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., Veeva DataOps Coaching Metadata Leadership Management Governance Innovation Semantic Web Communication Advertisement Data Modeling Pharmaceuticals Data Governance Data Management Team Leadership Data Engineering Data Architecture Influencing Skills Collibra (Software) Delivery Performance Alation Data Catalog Operational Excellence Software Documentation Artificial Intelligence Product Lifecycle Management Continuous Improvement Process

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, Leadership Automation Governance Innovation Creativity Statistics Compassion Scalability Informatics Data Quality Data Science Data Analysis Presentations Data Integrity Regulatory CMC Bioconjugation Business Acumen Problem Solving Data Management Computer Science Telephone Skills Change Leadership Organic Synthesis Biopharmaceuticals Influencing Skills Advanced Analytics Business Valuation Strategic Thinking Leadership Studies, Regulatory Compliance Scientific Literature Stakeholder Management Stakeholder Engagement Digital Transformation Mathematical Chemistry Professional Networking Computational Chemistry Pharmaceutical Sciences Self Service Technologies Data-Driven Decision Making Product Lifecycle Management Scrum (Software Development) Continuous Improvement Process Enterprise Application Software Generative Artificial Intelligence Biologics License Applications (BLA), Leadership Management Innovation Biomarkers Immunology Collections Peer Review Data Quality Self-Starter Life Sciences Data Exchange File Transfer Data Cleansing Data Reporting Pharmaceuticals Clinical Trials Data Structures Decision Making Immune Disorder Data Management Medical Devices Data Collection Drug Development Data Integration Data Acquisition Vendor Management Trial Master File Solution-Oriented Industry Standards Data Documentation Emerging Technologies Operational Databases Cardiovascular Disease Sustainable Development Pre-Clinical Development Clinical Data Management Interpersonal Communications Electronic Data Capture (EDC) Good Clinical Practices (GCP) Continuous Improvement Process

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.