Daiichi Sankyo Inc. Associate Director, Senior Clinical Data Programmer in Basking Ridge, New Jersey

9458BR

Auto req ID:

9458BR

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 Senior Clinical Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and coordinating with external vendors 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

  • Serve as a subject matter expert and provides expertise for programming.

  • 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.

  • Create and maintain specifications as per CDISC SDTMIG.

  • Define and create ad-hoc reports and listings for clinical teams.

  • Develop, implement and maintain SAS programming standards.

  • Review annotated case report forms and database structures.

  • Manage or lead programming assignments as necessary.

  • 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.

Qualifications:

Education

  • BA/BS degree required, MS degree desired.

Experience

  • Minimum of 7 years SAS and clinical programming experience in the biotech/pharmaceutical/ CRO industry.

Competencies

  • Project management and team leadership experience.

  • Knowledge of CDISC, CDASH and SDTM is a must.

  • Knowledge of reporting tools: JReview, Spotfire are preferred.

  • 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.

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.

Job Title:

Associate Director, Senior Clinical Data Programmer

City:

Basking Ridge

Functional Area:

Research & Development

State:

New Jersey