Statistical Programming Manager

vor 3 Wochen

Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
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, specification development for SDTMs and ADaM datasets, and SAS program development and validation.
  • Contribute to the development and validation of SAS programs to create SDTM and ADaM datasets and TFLs.
  • Ensure timely and accurate completion of Statistical Programming deliverables.
  • Participate in drafting requests for proposal for CRO selection and review baseline budgets and timelines.
  • Contribute to budget management and activities across the project duration.

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.
  • Experience in oncology Therapeutic Area and/or in late-phase projects is an advantage.
  • Excellent English language skills.
  • Good understanding of GCP and GDPR principles.
  • Good communication skills, both oral and written, in explaining complex concepts in simple terms.
  • Advanced working knowledge of SAS language, procedures, and options commonly used in clinical trial reporting.
  • Previous experience supporting SAS macro and/or system utility development is preferred.
  • Solid knowledge of new advanced statistical methods using SAS.
  • R knowledge is highly recommended but not required.
  • Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.
  • Fundamental negotiation and project management skills.
  • Ability and interest to work remotely with worldwide team members across cultures and time zones.

Why Work with Us?

At Daiichi Sankyo Europe, we are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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