The Position
What does our department do?
Our department supports the technical development of new medical tests and their evaluation in submission studies. We strive for providing doctors and patients the best support available for diagnosis and treatment of diseases with an urgent, but yet unmet medical need.
What will you do?
For our expanding international team at Penzberg Germany and Indianapolis USA, we are searching for a new colleague (m/f/d) who will support submissions for diagnostics tests and contribute programming to our analysis tools.
Join us in delivering a valuable contribution to our society, according to our motto “Doing now what patients need next”.
How does a typical working day look like for us?
* 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 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. The great choice of dishes makes it hard to decide. A coffee with your colleagues helps you start the second half of your day.
* 1:00 pm - A phone call 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 finalize 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 - You next have a meeting 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 support our team with your knowledge and experience?
* You have a university degree with high grades (Master/Diploma, PhD) in (Bio-)Statistics or Mathematics, Physics, Psychology, Data Science, Bioinformatics or a comparable degree and 2 year's working experience
* You are open to new solutions and are confident that you can contribute soon your statistical expertise and analytical skills to your projects
* You are proficient in programming with 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 processing 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 and explaining your work to the project team and to stand to your opinion
* You appreciate teamwork with scientists from very diverse fields, you 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 e.g. to Germany, Switzerland and the US, we are the right place for you
Application documents
For your application, please add an updated CV, references and your study certificates (Bachelor, Master, PhD).
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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