Manager, Data 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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.

Summary

The Manager, Data Programming is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating 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 SAS programs for clinical trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously.

Responsibilities

• Perform all programming tasks required to support Data Management and Biostatistics, as necessary.
• Perform validation and QC/QA of CDISC, SDTM domain output in accordance with SOPs, SOIs, and guidance documents.
• Manage external vendors and ensure accurate and high-quality deliverables.
• Ensure documentation and consistent maintenance of code, logs and output within a regulated computing environment.
• Create and maintain specifications as per CDISC SDTMIG.
• Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.
• Develop, implement and maintain SAS programming standards and performs quality checks.
• Review annotated case report forms and database structures.
• Develop reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient profiles on an ad hoc basis to support the Biostatistics, Data Management, and clinical teams.
• Mentor and train other associates within Data Management, as necessary.
• Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
• Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
• Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
• Review deliverables before transfer to either internal or external clients ensuring quality.

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

Education Qualifications (from an accredited college or university)

• Bachelor's Degree required
• Master's Degree preferred

Experience Qualifications

• Minimum of 6 years with a B.S. or 4 years with a M.S. of SAS and clinical programming experience in the biotech/pharmaceutical/CRO industry is required
• Exceptional understanding of clinical data and generating exceptional listings
• Hands on knowledge of Spotfire or J-Review is a plus
• Prior experience working with vendors and stakeholders
• Good communication skills and an ability to work cross-functionally 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.