Data Programmer Lead, Biostatistics and Data Management
19 hours ago
Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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 cardiovascular diseases, 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.
The estimated salary for this position is $80,000 - $110,000 per year, depending on experience and qualifications.
About the Role
- This role involves performing 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 includes developing and validating SAS programs for clinical trials. The successful candidate 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.
Key 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
- Bachelor's Degree required
- Master's Degree preferred
- Minimum of 5 years (w/B.S.) or 4 years (M.S.) SAS and clinical programming experience in the biotech/pharmaceutical/CRO industry 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.
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San Francisco, California, United States Daiichi Sankyo, Inc. Full timeUnlock the Power of Pharmaceutical InnovationDaiichi Sankyo Group is a pioneer in creating innovative pharmaceutical therapies to enhance global healthcare standards. With over 125 years of scientific expertise, we leverage cutting-edge science and technology to address diverse unmet medical needs worldwide.We are dedicated to providing novel therapies in...
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