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- 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.
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- 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.
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- Minimum of 6 years (w/B.S.) or 4 years (M.S.) SAS and clinical programming experience in the biotech/pharmaceutical/CRO industry required
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Manager, Data Programming and Reporting - Trenton, United States - Daiichi Sankyo
Description
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 / Senior 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.
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
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)
Experience Qualifications
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success.We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration.
We provide employees with the training, tools and technology that they need to excel.Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized.
We invite you to consider a career at Daiichi Sankyo, Inc.
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