The pharmacometrician/ system engineer and data analyst M&S (PMX) performs MIDD activities (e.g., exposure response analysis, disease progression modeling, quantitative knowledge management, clinical trial design, and M&S strategy) for development projects starting prior to FIH trials up to successful regulatory approval and beyond.
The PMX is responsible for the strategic design and risk assessment of complex systems over their life cycles. The ultimate goal of the conceptual work in the field of modelling and simulation is to understand the various levels of requirements, the domain, the viable technologies and to anticipate the needs for the general strategy for further development of the technical systems. Additionally, budgeting, detailed project/system planning, implementation, maintenance, and monitoring are essential tasks to ensure continuous optimization. The system engineer and data analyst ensures also that the system is appropriately documented and compliant with all regulatory requirements.
Furthermore, PMX is proactively contributing to the scientific knowledge and advancing operational capabilities by providing state of the art population PK/PD analyses, alternative approaches and concepts and automated solutions to support M&S scientists on their daily tasks. Important focus is to accurately and fully record and conduct population PK analysis, PK/PD analyses and simulations in an auditable manner consistent with GXP practices (where applicable) and defined global principles to guarantee institutional memory.
The PMX provides access, assistance and training to all users working in cross-functional and international environment.
Strategic design, risk assessment, budgeting, planning, implementation, maintenance, and monitoring of the technical systems used for M&S activities
Anticipate and implement alternative concepts and technical automated solutions
Ensure that the system is appropriately documented and compliant with all regulatory requirements
Conduct population PK analysis, PK/PD analyses and simulations for global development projects in an auditable manner consistent with GXP practices (where applicable) and defined global principles to guarantee institutional memory
Provide access, assistance, and training to all users
Contribute to the scientific knowledge and mentor less experienced colleagues within the global organization
Academic background in Computational Sciences
Broad knowledge of the information systems environment and technologies (infrastructure & applications) and experience in the design, planning and implementation of complex systems.
Ability to exercise independent judgment and creative problem-solving techniques in a highly complex environment, using leading-edge technology to form a coherent, comprehensive, and robust solution.
Excellent oral and written communication skills as well as an ability to present and discuss technical information in a way that establishes rapport, persuade others, and gains understanding.
Ability to work in networked organizational structure; a team player comfortable mentoring and assisting others.
Technical expertise in majority of the following areas: Clinical trial simulation technologies, PK modeling, PBPK modeling, population PK modeling, PK/PD modeling
Broad knowledge of Linux operating system
Experience with high scripting languages such as R and Perl
Experience with software solutions such as NONMEM, Monolix and PsN
Experience with reusable document systems such as LaTex, Beamer and Markdown
Preferably experience with additional programming languages such as C++, Java and Python
An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
An individual and well-structured introduction and training of new employees.
You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
As a globally successful and constantly growing company, Sanofi provides international career paths as well.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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