Associate Director, Biostatistician (all genders) - part-time possible

Posté 19 oct. 2022

Darmstadt, Hessen - Germany

Demander un identifiant 257413

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your Role:
The Associate Director Biostatistician provides statistical contribution to the product strategy in Medical Affairs and statistical support to study designs and exploratory analyses needed for the life cycle management of product of value for the patient. You will provide the CRO oversight in delivering accurate studies statistical activities; ensuring statistical analyses and adequate objective interpretation together with the results reporting & publications.
You will be able to provide statistical leadership in the development of the different human research study designs in Medical Affairs and take accountability for the statistical matters. You ensure that the planning and management of outsourced statistical results (including statistical programming) are effectively performed and are conducted to the highest quality and in a timely manner. When required, you write and develop the statistical analysis plans for human subject’s studies, coordinated safety summaries, and integrated efficacy summaries. Furhtermore you will 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. When required, you ensure that health care providers understand new product differentiation and safety. You collaborate cross-functionally providing statistical expertise and designing and conducting studies to address health care provider’s clinical questions 

 
Who You Are:

  • Ph.D. or Master in Statistics, Biostatistics or related field
  • At least 8-10 years of experience in the Pharmaceutical/Biotechnology industry in clinical development 
  • Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions including medical affairs
  • R and SAS practical and effective knowledge
  • Excellent knowledge of ICH and other relevant guidance documents (from ICH, FDA, EMEA, etc.), using them pro-actively to impact the performance or find alternative solutions
  • Ability to interact with statistical experts, key opinion leaders, HTA authorities, Health Care Providers
  • Ability to ensure efficient collaboration between the Biostatistics Department and the Contract Research Organizations, Vendors, External Partners, and Data Monitoring Committees

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Postuler