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Senior Manager Biostatistics

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Company Overview

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter.
For more information, visit our website.

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

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

How to Apply

To apply for this vacancy, please click here.