Statistical Programming Manager

hace 3 días

Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo
Job Title: Manager Statistical Programming

About the Role:

We are seeking a highly skilled Manager of Statistical Programming to join our team at Daiichi Sankyo Europe. As a key member of our Statistical Programming department, you will be responsible for 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.

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 to support SDTMs and ADaMs.
  • Ensure timely and accurate completion of Statistical Programming deliverables and contribute to documents submitted to Regulatory or Pricing Authorities.
  • Comply with international regulations and maintain inspection readiness, ensuring inspection readiness as well as preparing potential audits linked to assigned studies.
  • Participate in drafting request for proposal for CRO selection and reviews baseline budget and timelines.

Requirements:

  • Working knowledge of Statistical Programming applications and industry standards.
  • Moderate technical skills in working with data received from CROs and other third-party vendors.
  • Ability to partner with internal and external stakeholders to optimize Statistical Programming technology, processes, and standards.

About Us:

Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. We focus on two areas: protecting people from cardiovascular disease and helping patients who suffer from it to enjoy every precious moment of life, and becoming a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

What We Offer:

We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.

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