Boehringer Ingelheim ranks among the world's 20 leading pharmaceutical corporations. Our vision drives us forward. It helps us to foster value creation through innovation in our company and to look to the future with constantly renewed commitment and ambition.

Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach is the most important research and development site of the worldwide Boehringer Ingelheim Corporation and the company's centre for biotechnological development and manufacture.

Biostatistician m/f

Opportunity for Statistician and Mathematician (Statistiker / Mathematiker)

Job ID: 4000 2592 BC 12/11 2
Location: Biberach
Division: Medicine
Boehringer Ingelheim Pharma GmbH & Co. KG

Are you looking for a challenging job that will allow you to apply and develop the knowledge and skills you have acquired during your studies and in practice?

Then join our motivated biostatistics team and work in an international environment as a project and study statistician in clinical drug development. A demanding and rewarding position awaits you in beautiful south Germany!

Your role and responsibilities

Your primary responsibility will be to work as a statistician in the clinical development of new drugs - starting from phase I up to registration and launch. The position involves working closely with physicians, data managers and programmers in international project and study teams.

Your responsibilities as a Study Statistician (phase I - IIIb):

• Planning and decision making for state-of-the-art study designs, evaluating methods and performing sample size calculations
• Developing study protocols in collaboration with study physicians
• Participating in the monitoring of study conduct to oversee data quality and potential implications for the planned analysis
• Responsibility for study evaluation and reporting through creation of a statistical analysis plan, performing the inferential statistical analysis
• Writing integrated reports and scientific publications in collaboration with the study physician and medical writer

Your responsibilities as a Project Statistician:

• Planning statistical aspects of clinical development plans, in close collaboration with the medical project leader and other members of the global project team
• Providing answers to project related statistical or methodological questions from decision-makers inside and outside the company
• Writing detailed statistical project plans and stipulating requirements and standards for study teams
• Providing guidance to study statisticians on protocol development, analysis plans, study reports and publications
• Planning and compiling clinical registration dossiers
• Preparing regulatory documentation for the EU and the USA, in collaboration with project physicians and data managers
• Discussing statistical issues with drug regulators

You will be expected to have an MSc or PhD degree in statistics or mathematics as well as a comprehensive knowledge of biostatistics. You should also be familiar with the application of new statistical methods and theories in software solutions involving SAS or R. Experience as a project or study statistician in clinical development is considered a major advantage.

You will be expected to be self motivated, a good communicator and team player, have a firm grasp of the English language, and enjoy working on challenging scientific projects and studies in an international setting.

We provide an attractive compensation and benefits package. Biberach is situated in an attractive area of southern Germany between Stuttgart and the Lake of Constance.

If you are seeking opportunities to expand your professional horizon and your profile corresponds with the above we look forward to hearing from you.