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Associate Director Biostatistics (m/f)

Posted 05 Sep 2018

Darmstadt, Hesse - Germany

Req Id 181324

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 
 


Your role:
You provide statistical leadership for informative decision making to optimize probability of success of new product development. You oversee the CRO in delivering proper studies statistical activities; ensuring statistical analyses adequate objective interpretation together with the results reporting & publication(s), with management support, defend statistical design and results interpretation towards Health Authorities and Key External Experts. You provide statistical leadership in the development of the different human research study designs and take accountability for the statistical matters. Furthermore, you ensure that the planning and management of outsourced statistical deliverables (include statistical programming) are effectively performed and are conducted to the highest quality and in a timely manner. You perform statistical analyses of study data and validate analysis results and ensure objective results interpretation and internal communication for studies or integrated summaries in support for informative decision making in consultation with line management. You ensure preparation of data package for file submission to health authorities with line management supervision.

 

Who you are:

  • Master’s degree + 8 years’ experience or PhD + 5 years of experience in the Pharmaceutical/Biotechnology industry in clinical development with experience in Neurology, MS strongly preferred
  • Experience supporting global regulatory submissions is required. Knowledge of CDISC submission and integrated safety and efficacy summary
  • Experience of project management as global statistical leader, preferably exposed to a multicultural environment.
  • Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions.
  • Excellent knowledge of ICH/GCP and other relevant regulations.


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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