Lead Biostatistics Program Manager
Vor 3 Tagen
Job Description
Daiichi Sankyo Europe is seeking a highly skilled Lead Biostatistics Program Manager to join our team. This exciting role will involve managing the end-to-end delivery of Statistical Programming services for assigned studies, collaborating with CROs and other vendors to ensure high-quality deliverables are on time and within budget.
Responsibilities:
- Manage study-level statistical activities, including SAPs and TFL shells review from a programming perspective, contribute to develop specifications for SDTMs and ADaM datasets, and demonstrate knowledge with XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs.
- Contribute to documents submitted to Regulatory or Pricing Authorities and must comply with international regulations and maintain inspection readiness.
- Oversight of vendor delivery, ensuring compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
Requirements:
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required; master's degree in bio/statistics preferred.
- At least 2 years of experience supporting drug development and/or post-marketing in clinical research, Pharmaceutical, CRO, or Medical Device setting.
- Excellent English language skills and good understanding of GCP and GDPR principles.
- Advanced working knowledge of all SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
- Fundamental negotiation and project management skills and ability to work remotely with worldwide team members across cultures and time zones.
Why Work with Us?
We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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