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Global Director Biostatistics (m/f/x)

Daiichi Sankyo

Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

For our global team in Europe we are seeking highly qualified candidates to fill the position of Global Director Biostatistics (m/f/x).

The position

      The position holder will be responsible for leading biostatistical strategy and accountable for biostatistical activities for Global Medical Affairs and Global Market Access and Pricing activities for one compound. The relevant responsibilities will include the development of the data strategy for Medical Affairs and HEOR activities including coordinating HTA interactions.

      This position will represent Biostatistics and Data Management department at the Global Project Teams of Medical Affairs and Market Access including the Publication Team.
      This position works under minimal supervision to conduct his/her activities and to solve complex project problems. The position holder will show statistical leadership, strategic thinking and excellent communication skills in the interactions with internal and external stakeholders (key opinion leaders, regulatory and pricing agencies) and in addition may coordinate other statisticians assigned to the same project. This position may lead a small team of statisticians.

      Roles and responsibilities

      • As a statistical expert he/she provides oversight of activities in assigned projects under accountability performed by direct report and biostatisticians assigned to his/her project across the global/regional evidence generation activities and ensures that the global evidence generation strategy is properly represented into the global/regional biostatistical activities conducted on the project
      • Provides input to the evidence generation plan to ensure the biostatistical strategy and execution will meet GMA and GMAP strategy
      • Ensures that the proposed evidence generation activities are scientifically sound and have appropriate designs in order to answer efficacy and safety questions to be submitted to external stakeholders including pricing agencies for countries and regions the drug is to be submitted
      • As project statistician accountable for the statistical deliverables in his/her project, ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project
      • Leads the global project team in using the most efficient or innovative study design by considering the agency requirements for the targeted country and regions the compound will be submitted and helps to maximize the success of the drug product
      • Leads statistical activities globally for very complex studies or an entire project. This includes at least the development of study protocols, analysis plans and analysis execution and interpretation for clinical studies, non-interventional studies, RWE activities, external control arm studies and all the other clinical data activities within the scope of evidence generation
      • Participates in drafting request for proposal for CRO selection globally, including timelines, budget and activities across the project duration
      • Leads CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high-quality deliverables
      • Oversees the biostatistical process for developing and executing statistical analyses for national Pricing Authorities submissions
      • Develops and reviews value dossier, IIS, Literature Reviews, RWE. Coordinates biostatistical activities for publications and may author documents and responses submitted to Pricing Authorities globally with some guidance from supervisor
      • Leads global BDM initiatives to improve the harmonization and efficiency of drug development with minimal supervision

      Professional experience and personal skills

      • Minimal 10 years of experience in the pharmaceutical industry in drug development or evidence generation of which at least 5 in evidence generation space
      • Master’s degree or higher in statistics or mathematics or strictly related fields and demonstrated expertise in study design and data analysis
      • Extensive experience in Oncology Therapeutic Area in conducting clinical programs and studies and in programming in SAS and/or R
      • Experience in late phase projects is an advantage
      • Excellent communication, collaboration and project planning skills

      What we offer

      Working at Daiichi Sankyo

      At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done

      How to Apply

      Click here to apply for this position.