Manager, Data Management Database Programming

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Job Summary:

The Manager, Data Management Database Programming is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Standards, Process, and technology. Accountable for the quality of the Data Management programming, reporting and visualization, standard and exception data listings. Provide Spotfire subject matter expertise, and support vendor with all study and database related queries before and after study setup in Spotfire. This position involves exercising sound and independent judgement in developing programming methods, techniques, and evaluation criteria to achieve the desired results. Provides guidance and expertise on industry best practices applied to data management, study teams, and other stakeholders on complex patient profiles, subject narratives, dose modification listings, and data integration of different clinical systems to streamline, enhance efficiencies and improve the quality of data management processes. This position will work closely with other members of the Biostatistics and Data Management, external CRO partners, and other stakeholders.

Responsibilities:

• Serve as a subject matter expert and provide expertise for Database programming, Reporting, and Technology including Spotfire, JReview, and other Data Management Systems, Standards, and Processes.
• Manage the quality of the data management clinical database programming deliverables including edit checks programming, complex reports and listings; patient profiles, subject narratives, dose modification listings, and other adhoc reports, as required by the study teams.
• Work closely with the study teams to develop specifications, support reporting and visualization capabilities, provide data insights, facilitate user acceptance, testing, and training on the Spotfire Platform, as required.
• Collaborate with CRO partners to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of Spotfire or other visualization tools.
• Contribute to database design and programming specifications/definitions in consultation with Biostatistics and Data Management.
• Oversee the CRO database programming deliverables and ensure the delivery on time, quality and budget.
• Lead and manage external vendors and ensure accurate and high-quality deliverables on clinical database development, database programming, reports and metrics.
• Builds/tests programs for data validation derivation procedures, data reports, listings, and SAS On-demand Relational Database Extracts to identify inconsistencies and support clinical data review activities.
• Provide technical expertise and programming support for Medical Coding activities.
• Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including interim analysis, and database lock activities.
• Support the integration of clinical data from various sources including EDC to enhance efficiencies and quality of data management processes and deliverables.
• Mentor and train other data associates within Data Management, as necessary.
• Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies and guidelines.
• Stay current on industry trends, best practices, data standards, and clinical programming methods, techniques and other technologies of importance to enhance business capabilities, improve quality and achieve operational efficiencies.
• Provide insights and/or recommendations to streamline data management information flow, enhance business efficiencies, and improve quality.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

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

• Expertise in Clinical Programming, methods, and techniques
• Strong knowledge and expertise in industry standard reporting and data visualization tools including Spotfire, JReview, Business Objects, and SAS suite of tools
• Strong knowledge of industry standard clinical technologies including CTMS, EDC (RAVE, InForm), Veeva Vault, IRT, and Clinical Portals
• Strong knowledge of data standards - CDASH, SDTM/ADaM, CDISC
• Minimum of 5 years database programming experience and data validation programming in the device/pharmaceutical/CRO industry
• Strong knowledge and understanding of relational databases
• Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required

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.

Job Title
Manager, Data Management Database Programming

City
Basking Ridge

Functional Area
Biostatistics & Data Management

State
New Jersey