Biostatistician at Roche

The Position

Impact Healthcare

• Join us as a Biostatistician (2 year contract position) at Roche Diagnostics Cape Town and apply your passion for informatics and data analytics to solutions that are enabling the actualisation of personalised medicine and precision healthcare. The position is within Clinical Biostatistics, which is part of the Computational Science and Informatics (CSI) functional area. Our department supports the technical development of new medical tests and their evaluation in submission studies. We strive for providing doctors and patients with the best support available for diagnosis and treatment of diseases with an urgent, but yet unmet medical need. Your functional leadership will be in Penzberg, Germany but you will join and interact with local CSI colleagues in the Bioinformatics team. You will benefit from broad exposure to the global CSI organisation’s diverse activities.
• Join us in delivering a valuable contribution to society according to our motto “Doing now what patients need next”.
• What does a typical working day look like?

Note that due to the pandemic, we currently work in a hybrid mode, with at least one day per week on site, and the rest from home.

• 8:00 am – Today, you have your first meeting with Regulatory Affairs and Clinical Operations. The feedback from the authorities on the submission of a study is discussed
• 9:00 am – Test development in Germany calls you. An assay shows a negative component of variance. You explain the background for this finding. Overall, precision is worse than expected. You evaluate the factors that may be responsible for this, and provide an analysis report
• 12:00 noon – Lunch break with colleagues in the cafeteria, if you are on site. A coffee with your colleagues helps you start the second half of your day
• 1:00 pm - A meeting with a US Study Manager about the design of an upcoming study is in the calendar now. You want her approval for the primary analysis so that you can finalise the sample size calculation for the statistical analysis plan
• 2:00 pm - Then you proceed with developing your R package for test development. You add functions and document in parallel the requirements for their validation in the document management system
• 4:00 pm – Your next meeting is with your study team. You present your results of an interim analysis of a study, discuss its impact on the project with the team and assign action items
• 5:00 pm - It’s time to finish up and see what is planned for tomorrow

How can you actively contribute to our team with your knowledge and experience?

• You have a Masters in (Bio-)Statistics, Data Science, Bioinformatics or another quantitative discipline. An advanced degree is highly preferred and post Masters experience would be a plus
• You are open to new solutions, and you are confident that you can contribute your statistical expertise and analytical skills to your projects
• You are proficient in programming, ideally in R or SAS
• Ideally, you have gained experience in modelling statistical problems in an industrial environment
• You are familiar with regulatory requirements for planning and analysing clinical studies; ideally, you already have practical experience
• You are able to explain complex statistical topics in a plain way to your customers
• You enjoy presenting your work to the project team in an explanatory way and to stand to your opinion
• You appreciate teamwork with scientists from very diverse fields, are able to consider their needs and to develop solutions together
• Your English is fluent, both spoken and written
• If you are also willing to take occasional business trips (10%), e.g. to Switzerland and the US, we are the right place for you