- Our company is the world’s leading inspection, verification, testing and certification company.
- The company employs over 86.000 people and operates a network of more than 1000 offices and laboratories around the world.
- One of the business segments, Clinical research, is a leading Contract Research Organization (CRO) providing drug development and post-approval services to the pharmaceutical and biopharmaceutical industry.
In this position you will be responsible for the generation, validation and communication of the statistical results for multiple clinical research projects in a wide variety of therapeutic areas.
- Able to work independently and collaboratively, your primary responsibilities will include:
- Participate in building the design of a clinical trial protocol, with inclusion of sample size calculation
- Write and review the statistical analysis plan for phase I to IV trials
- Develop Table Shells and specifications on CDISC ADaM datasets
- Program and validate the statistical analysis, possibly in co-operation with other Biostatisticians and/or Statistical Programmers
- Pay special attention to the inferential statistics with inclusion of thorough quality control by double programming
- Communicate to the Data Manager on database topics to guarantee reliable conclusions
- Create high-quality graphs for visualization of data and analytic results
- Review the Clinical Study Report and support the Medical Writer in the interpretation of the statistical results
- Work in close collaboration with the Biostatistical Coordinator and other colleagues
- Master of Science in (Bio)Statistics
- Strong experience with SAS
- At least 5 years of relevant experience in clinical research as a biostatistician
- Fluent in English
- ICH-GCP knowledge