Principal Scientist

vor 8 Monaten

Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**THE POSITION**:
You will also have the exciting prospect of acting as a Data Science Lead (DSL) in clinical development project teams to fulfill our vision of turning data into knowledge. As DSL, you’ll have the chance to shape and contribute to projects already prior to first-in-man clinical trials.

If you would like to learn more on the vision and mission of our TMCP Data Science department, please see below in TMCP Data Science Section.

This position can be filled in Ingelheim or Biberach.

**Tasks & responsibilities**:

- As a Principal Scientist in Pharmacometrics, you will develop the pharmacometrics strategy and identify opportunities where pharmacometrics and other advanced data analytic approaches can further the understanding of pharmacological activity, efficacy and safety of a drug.
- advising clinical development teams on opportunities and limitations of Data Science approaches (e.g. pharmacometrics, computational biology, systems pharmacology, descriptive analytics)
- developing and aligning the project TMCP data and data analysis strategy and ensuring its execution
- Furthermore, you will be responsible for the planning and execution of relevant pharmacometric analyses to support internal decision making, disease understanding and successful approval.
- You will ensure the timely delivery of respective data analysis documents (e.g., dataset specification, analysis plans, and reports) and documents where you are co-author (e.g., clinical development plans).
- Moreover, you will organize and manage projects with external organizations such as academic institutions or CROs.
- You will continuously evaluate and implement novel pharmacometric approaches and may support or drive the development of quantitative methodological approaches, pharmacometrics (software) tools, and related business processes.
- You will represent PMx/Data Science in internal and external initiatives/working groups such as focus groups in your therapeutic area of expertise, across department initiatives, process harmonization, IMI calls, ISoP groups, Open Systems Pharmacology.

**Requirements**:
We expect a strong team player, who is able to successfully act in the global and remote context. Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., CROs, experts, management) and the ability to pro-actively identify issues and solutions and to interact with internal and external bodies on TMCP data science issues are a pre-requisite.
- PhD., MD or master’s degree from an accredited institution in Medicine, Pharmacometrics, Data Science, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus
- Multi-years of relevant experience in Pharmacometrics/Data Science in the pharmaceutical industry, CROs, regulatory agencies, or academia
- Several years of relevant experience in working in clinical development teams

**TMCP Data Science**:
Within TMCP Data Science we are focusing on improving disease, biomarker and drug understanding through modern data science approaches, including bioinformatics, systems pharmacology, pharmacometrics, data enablement and data engineering.

To implement our vision of turning data into knowledge, we utilize our scientific expertise in key data science approaches and act as Data Science Leads in development project teams. In this role you will be a main contact for data science related questions supported by the whole TMCP Data Science group. You will join the clinical development team approximately two years before first-in-man clinical trials and support projects until successful regulatory approval and beyond.

We inspire and empower data scientists within TMCP to shape the future of Data Sciences at BI and value a culture of sharing knowledge, pro-active contributions, and feedback combined with a positive “how to” attitude also in challenging situations. Within TMCP Data Sciences you will have the opportunity to actively contribute or lead internal and external working groups/initiatives focusing on e.g. disease strategies, innovative methods, standardization and processes. Thus, you will have a major impact on our future clinical drug development programs, thereby actively contributing to the availability of breakthrough therapies that will increase human health.

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