Manager, Clinical Database Application & Reporting in Bernards, NJ at DSI

Date Posted: 4/26/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary

The Manager, Clinical Database Application and Reporting is a member of the Biostatistics and Data Management team and performs database programming tasks, provides expertise on clinical data reports and collaborates with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required for clinical trials. These include developing and validating programs used for reporting and visualization of clinical data. This position will work closely with other members of the Biostatistics and Data Management, and other cross functional teams on various clinical projects and may function as the Lead of Clinical Database set-up and reporting.

Responsibilities
  • Serves as a subject matter expert in clinical database programming and on reporting tools (e.g. Spotfire, Business objects 4.1…) to support Biostatistics, Data Management and other key stakeholders.
  • Oversees the development, maintenance, and compliance of standard reports to support clinical studies utilizing, but not limited to, Global Objects, CRF modules and external data.
  • Develops reports & visualizations in Spotfire to enable holistic data review. This includes developing algorithm for patient profiles, data plots (efficacy, trends…) and ad-hoc reports to support the Biostatistics, Data Management, and clinical teams.
  • Manages external vendors and ensures accurate and high-quality deliverables.
  • Creates and maintains specifications for standard reports and visualization.
  • Authors SAS programs to generate complex data review listings and reports to ensure data quality, consistency, and validity to support Data Management and clinical teams.
  • Develops implements and maintains SAS programming standards for ad-hoc and standards SAS listings for data review purposes.
  • Reviews annotated case report forms and database structures.
  • Mentors and trains other associates within Data Management, as necessary.
  • Participates in the development of Standard Operating Procedures (SOPs), policies, and guidelines and ensures compliance with regulatory guidelines.
  • Stays informed of the emerging technologies and processes improvements in programming space that are relevant to the industry and contributes to the innovation of new reporting systems.
  • Establishes and implements programming standards and comply with regulatory requirements among project team members and across all studies.
  • Review deliverables to ensure quality prior to sharing them with either internal or external clients.
Qualifications

Education
  • BA/BS degree required, MS degree desired.
Experience
  • Minimum of 5 years database programming experience designing studies and data validation programming in EDC required; RAVE/Medidata Solutions preferred.
  • Expertise with reporting tools; Spotfire, J-Review, Business Objects 4, SAS, are preferred
  • Database design and clinical programming experience in the biotech/pharmaceutical/ CRO industry.
  • Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
  • Knowledge of industry standards; CDISC-SDTM/CDASH preferred
  • Experience with external data handling of study data preferred
Competencies (Optional)
  • Project management and team leadership experience.
  • Knowledge of CDISC, CDASH and SDTM is a must.
  • 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.
  • Proficient computer skills across multiple applications.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.