Statistical Programming Manager

hace 4 semanas

All, Gerona, España Daiichi Sankyo Europe A tiempo completo

About Us

Daiichi Sankyo Europe is a leading pharmaceutical company with over 120 years of experience and more than 17,000 employees in over 20 countries.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

We are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

About the Role

We are seeking an experienced Manager Statistical Programming to join our team in Europe.

The successful candidate will be responsible for managing 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.

The position holder will partner with internal and external stakeholders to optimize Statistical Programming technology, processes, and standards.

Key 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.
  • Ensure timely and accurate completion of Statistical Programming deliverables and contribute to documents submitted to Regulatory or Pricing Authorities.
  • Oversight of vendor delivery, to ensure 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, good understanding of GCP and GDPR principles, and good communication skills, both oral and written.
  • Advanced working knowledge of all SAS language, procedures, and options commonly used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
  • Solid knowledge of new advanced statistical methods using SAS and R knowledge highly recommended but not required.

Salary

The estimated salary for this role is €60,000-€80,000 per annum, depending on experience.

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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