For our Data Science Department, we are looking for an experienced, communicative and proactive (Clinical) Statistician. The statistician provides expertise in the creation of research protocols and associated SAPs with an emphasis on prospective clinical trial design, power and sample size calculation, and hypothesis testing along with associated statistical methods. The Statistician will provide expertise in the creation, quality control and maintenance of clinical programming for the statistical outputs. The Statistician will support the review and/or development of study protocols, recognizing and highlighting statistical issues in collaboration with internal and external colleagues with minimal supervision. The Statistician will report to the Head of Data Science.
Tasks and responsibilities
- Creating or advising on study protocols or analysis plans across multiple therapeutic areas in collaboration with internal and external functional experts.
- Executing or overseeing the execution of study plans or protocols using either SAS or R which address data preparation, derivation of study variables (including CDISC as applicable), and performing statistical modelling and/or testing.
- Provide Quality Control for (statistical) analysis programs and deliverables.
- Follows internal and external procedures, best practice guidelines (e.g. ICH-GCP E9), and regulations. Provides project guidance on issues pertaining to regulations and guidelines.
- Collaborating with the project team to design the CRFs (in conjunction with a Data Manager), methodologies, and (statistical) techniques to address complex study objectives.
- Contributing to the development of innovative methodologies and new offerings. This includes ongoing central risk-based monitoring with extensions over time.
- PhD (with at least 5 years of experience supporting clinical trials) or a Master’s degree (with minimum of 8 years of experience) in Statistics (preferred), Epidemiology, or Mathematics;
- Strong background in trial design and statistical models ideally in a drug development setting (e.g. pharmaceutical industry, biomedical research);
- Experience in in supporting protocols, writing SAPs, and in the production of TLFs for clinical trials using SAS;
- Preferred to have strong understanding of how observational data sources can be used for statistical inference;
- Strong communications skills to explain and resolve statistical analysis issues, ability to communicate (verbal and written) technical and non-technical information clearly to a diverse audience.
An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.
We are located in a beautiful monumental building, close to Slot Zeist and close to public transport e.g. busses and train station Driebergen-Zeist. In the current COVID situation, our employees work from home as much as possible. After COVID we intend to offer the option of working from home, working at the office or a combination of the two.