Priya Mukherjee at CK Clinical is currently recruiting for a Biostatistician to join a leading pharmaceutical company based in Germany.
Biostatistician Job Description
As Biostatistician you will 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. Further responsibilities of this Biostatistician role will include:
- 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
- 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
As Biostatistician, you will have the following qualifications, skills and experience:
- An MSc or PhD degree in statistics or mathematics as well as a comprehensive knowledge of biostatistics.
- 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.
- Self motivated, a good communicator and team player
- Have a firm grasp of the English language
- Enjoy working on challenging scientific projects and studies in an international setting.
How to apply:
For more information, or to apply for this Biostatistician position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email email@example.com.