Manager, EDC System & Data Management Support (m/f/d)

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

This role is preferably based in France, with Munich as an alternative location. 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 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

Why work with us? Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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