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.
Job Summary
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 Qualifications
Bachelor's Degree required Master's Degree preferred
Experience Qualifications
- 4 or More 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 preferred
- Database design and clinical programming experience in the biotech/pharmaceutical/ CRO industry. preferred
- Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission required
- Knowledge of industry standards; CDISC-SDTM/CDASH preferred
- Experience with external data handling of study data preferred
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.
Salary Range:
USD$127,280.00 - USD$190,920.00