DSI

πŸ‘₯ 5001-10000ConsultingSecurityProfessional ServicesπŸ’Ό Private Company
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Daiichi Sankyo, Inc. (DSI) is a global pharmaceutical company dedicated to developing and delivering innovative therapies to improve patient care worldwide. With a legacy spanning over 125 years, DSI boasts a robust pipeline of promising new medicines, focusing primarily on oncology, rare diseases, and immune disorders, while also maintaining a strong portfolio in cardiovascular treatments. The company employs a collaborative and results-oriented culture, empowering its employees with the resources and technology needed to excel. DSI’s commitment to innovation is evident in its use of advanced technologies, including but not limited to, mobile-compatible applications, Google Analytics and Tag Manager, and a focus on robust cybersecurity measures (DNSSEC, HSTS). This commitment extends to its diverse workforce of 5001-10000 employees spread across more than 20 countries, with many positions offering a remote-by-design work model. DSI fosters a culture of open communication and personal accountability, valuing individual contributions while simultaneously encouraging teamwork. The company provides comprehensive training and access to cutting-edge tools, promoting professional growth and development. A significant emphasis is placed on operational excellence and continuous improvement across all facets of the business. Daiichi Sankyo’s global reach, combined with its dedication to cutting-edge research and development, positions it as a leader in the pharmaceutical industry. The company continues to expand its global footprint, showcasing a commitment to both innovation and its employees. Numerous job opportunities are available across various departments, offering career advancement potential within a dynamic and impactful organization. DSI consistently demonstrates its commitment to improving global health through its extensive research and development initiatives and a strong emphasis on employee success. The company's positive impact on the pharmaceutical landscape is a testament to its unwavering dedication to innovation and collaboration.

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πŸ‘₯ 5001-10000πŸ’° $378,215,525 Post-IPO Equity over 3 years agoπŸ«‚ Last layoff about 1 year agoMessagingSMSMobile AppsEnterprise SoftwareSoftware
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Jobs at this company:

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πŸ“ United States of America

🧭 Full-Time

πŸ” Pharmaceutical

  • Bachelor's Degree an accredited institution in a science or technical field preferred, Master's Degree preferred.
  • 10+ years of experience in the pharmaceutical industry or CROs with Bachelor's degree, 7+ years with Master's degree.
  • Experience supporting SAS macro or system utility development preferred.
  • Advanced working knowledge of SAS programming language in clinical trials.
  • Knowledge of CDISC SDTM and ADaM standards.
  • Understanding of statistical concepts for clinical trials analysis.
  • Familiarity with drug development phases.
  • Solid background in applied statistics.
  • Knowledge of advanced statistical methods using SAS and R.
  • Advanced knowledge in database structures and setup.
  • Support project lead on outsourced projects, act as subject matter expert in statistical programming.
  • Perform programmatic reviews of SDTM, ADaM datasets, and TLFs generated by vendors.
  • Provide programming support for regulatory submissions and develop submission strategies.
  • Create DSI programming standards and templates for datasets and TFLs.
  • Develop and maintain programming macros and tools to enhance efficiency.
  • Evaluate and improve DSI's computing environment system.
Posted 3 days ago
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πŸ“ United States of America

🧭 Full-Time

πŸ” Pharmaceutical

  • Master's degree in statistics or biostatistics required.
  • PhD in statistics or biostatistics preferred.
  • 10+ years of relevant experience in the pharmaceutical industry with a master's degree.
  • 7+ years of relevant experience in the pharmaceutical industry with a PhD preferred.
  • Leads statistical activities for very complex studies or an entire project.
  • Acts as statistical expert in assigned projects.
  • Guides project teams on efficient study design considering regulatory requirements.
  • Ensures consistency in data collection and analysis throughout the project.
  • Provides input to drug development plans to deliver expected product profiles.
  • Monitors CRO/vendor activities for high-quality deliverables.
  • Authors documents for global Health Authorities with minimal guidance.

Project ManagementData Analysis

Posted 3 days ago
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πŸ“ United States of America

🧭 Full-Time

πŸ” Pharmaceutical

  • Bachelor's Degree required; Master's Degree preferred.
  • 5+ years of direct Health Authority experience desired.
  • 10+ years professional experience at a management level.
  • 7+ years managing quality in an international, regulated healthcare environment.
  • Experience with biologics is a must.
  • Proven expertise in risk management, continuous improvement, and change management.
  • Experience working with global Health Authorities (FDA, EMA, etc.).
  • Strong knowledge of manufacturing processes and laboratory operations.
  • Solid understanding of quality management and cGMP/GLP requirements.
  • Responsible for leading inspection readiness activities, including mock inspections and support during regulatory inspections.
  • Executes evaluations of GMP readiness for manufacturing organizations, identifying and mitigating risks.
  • Ensures compliance for internal and external organizations in local and global markets.
  • Liaises with regulatory agencies on GMP QA issues.
  • Leads participation in project teams and contributes to achieving global QA vision.
  • Proactively supports QA programs and vendor selection processes.
  • Develops staff and fosters a quality culture within the organization.
  • Communicates effectively with stakeholders to drive compliance and continuous improvement.

Quality AssuranceRisk ManagementChange Management

Posted 6 days ago
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πŸ“ United States of America

🧭 Full-Time

πŸ” Pharmaceutical

  • Bachelor's Degree in Computer Science, Life Science, Engineering, or related discipline.
  • Master's Degree in Life Sciences or Information Systems preferred.
  • Minimum of 10 years experience in Pharma/Biotech/CRO with GXP validated systems.
  • Experience in R&D processes and business-IT liaison roles.
  • Excellent verbal and written communication skills.
  • People management experience of Business System Analysts, Project Managers, and Business Process Engineers.
  • Lead the administration and operational support of assigned business systems.
  • Manage project deliverables including user requirements, training, and documentation.
  • Ensure data quality and compliance across systems.
  • Monitor processes and propose improvements.
  • Collaborate with IT and other departments to achieve project goals.
  • Lead system-related inspections and manage project resources.

LeadershipBusiness AnalysisPeople ManagementStrategyCollaborationCompliance

Posted 2 months ago
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