Our Client
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 this your chance to join a 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 southern 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
Participate in the monitoring of study conduct to oversee data quality and potential implications for the planned analysis
Responsible 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
Skills & Experience Required:
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 soft-ware solutions involving SAS or R.
Experience as a project or study statistician in clinical development is considered a major ad-vantage.
You will be expected to be self-motivated, a good communicator and team player.
You will be expected to have a firm grasp of the English language.
We are looking for a professional who enjoys working on challenging scientific projects and studies in an international setting. Our client provides an attractive compensation and benefits package. The position is based in Southern Germany. If you are seeking opportunities to expand your professional horizon and your profile corresponds with the above we look forward to hearing from you.
To apply for this position please email Charlie Allen ([log in to unmask]) in the first instance with your most recent CV and contact number.
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