Manager, Data Management Database Programming in Basking Ridge, NJ at DSI

Date Posted: 8/9/2020

Job Snapshot

Job Description

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, 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 stakeholders with reporting, data listings, and data visualizations. Scope of work includes developing and validating programs used for reporting and visualization of clinical data. This position involves exercising sound and independent judgement in developing programming methods, techniques, and evaluation criteria to achieve the desired results. 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, ETL, SAS tools, and other Data Management Systems 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, exception listings, dose modification reports, and other adhoc reports, as required by the study teams.
  • Work closely with the study teams to develop specifications, support reporting and visualization capabilities, facilitate user acceptance, testing, and training on the Spotfire Platform, as required.
  • 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 Spotfire or other visualization tools.
  • 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.
  • 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.
  • Perform ETL tasks, enhancements, validation, and maintenance of the programs and templates on an ongoing basis.
  • Perform QC, develop validation scripts for user acceptance, execute programs and SMaRT View dry runs as needed, in preparation of user acceptance activities.
  • Develop and maintain mapping, and program specifications for standard reports, listings, and visualizations.
  • Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
  • Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.

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
  • 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

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.