Statistical Programming Expert

hace 1 mes

All, Gerona, España Daiichi Sankyo Europe A tiempo completo

About the Role:

The position of Expert Statistical Programming at Daiichi Sankyo Europe involves supporting the end-to-end delivery of Statistical Programming services for assigned studies. This includes collaborating with Contract Research Organizations (CROs) and other vendors to ensure high-quality deliverables are on time and within budget.

Key Responsibilities:

  • Study-level statistical activities, including review of SAPs and TFL shells from a programming perspective, contribution to develop SDTMs and ADaM datasets specifications, and creation of SAS programs to create SDTM and ADaM datasets and TFLs based on provided specs.
  • Vendor oversight, including routine oversight of vendor delivery to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies, SOPs, and other relevant guidelines.
  • Operational excellence and innovation, including participation in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.

Requirements:

  • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
  • Excellent English language skills, understanding of GCP and GDPR principles, good communication skills, and knowledge of SAS language, procedures, and options commonly used in clinical trial reporting.

About Daiichi Sankyo Europe:

Daiichi Sankyo Europe is 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.

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