Senior Manager Biostatistics (m/f/x)

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Date: 14-Oct-2021

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


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 headquarter in Munich we are seeking highly qualified candidates to fill the position of

 

Senior Manager Biostatistics (m/f/x)

 

The position:


The Senior Manager Biostatistics will be responsible for leading biostatistics strategy and activities for a compound and/or for individual clinical studies. This will include study level statistical deliverables such as study design, protocol developments, SAP, statistical analyses and study reports and responsibility for CRO management and oversight.
The position holder will be responsible to ensure statistical leadership during 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.
Support of publication activities as well as value dossiers preparation (e.g. AMNOG, NICE, etc.) is although the responsibility, to maximize the success for the Daiichi Sankyo portfolio in terms of Market Access.

 

 

Roles and Responsibilities:

Responsible for all assigned project and protocol level statistical deliverables and supports publication in projects

  • Protocol design, SAP, statistical analysis, reporting, publication, CRO
  • Coordination and oversight in close collaboration with project team(s) and Steering Committees
  • Ensures timely and accurate completion of bio statistical deliverables (internal tasks or tasks of CROs)
  • Ensures implementation of high quality, state of the art statistical methodology, efficient working processes

 

Support the development, execution and implementation of the European HEOR strategy

  • Planning, set-up and execution (by job holder or CRO) of additional statistical analyses as needed and requested by HEOR colleagues for national value dossiers
  • Review of value dossiers to ensure proper description of statistical components of the dossier
  • Participation in meetings with HEOR/HTA authorities

 

Broaden knowledge of statistical methodology in oncology and value dossiers

  • Continued effort to enhance and share experience and methodological knowledge internally with bio stats colleagues and other departments

 

Support other departments (Medical Affairs, Marketing, RWE & Clinical studies) in maximizing the success for the company portfolio

  • Ensure proper supports in publications and congress activities based on assigned project
  • Represent biostatistics internally and externally to ensure adequate implementation of statistical methodology

 

Personal skills and professional experience:

  • Minimal 5-8 relevant years of experience in drug development or post marketing
  • Master Degree or higher in statistics or related fields
  • Extensive experience in oncology Therapeutic Area in conducting clinical programs and studies
  • Experience in late phase projects is an advantage/welcome

 

 

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.