Manager, Data Programmer in Bernards, NJ at DSI

Date Posted: 4/15/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

The Manager, Data Programmer 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

Education
  • BA/BS degree required, MS degree desired.
Experience
  • Minimum of 6 years (w/B.S.) or 4 years (M.S.) 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: Spotfire and JReview 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.

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