Senior/Principal Biostatistician

at  BI Vetmedica GmbH

THE POSITION

Join the dynamic team at Boehringer Ingelheim as a Senior/Principal Biostatistician. This role is your chance to drive the statistical aspects of our animal health products’ clinical life cycle and ensure regulatory compliance. Here, you’ll shape departmental strategies, build partnerships, and lead in an industry committed to improving health. Seize these opportunities to make a real difference in a company that values innovation and progress.
This position is part time eligible with 75%.

REQUIREMENTS

• Ph.D. in statistics, biostatistics, or mathematics with several years of industry experience; alternatively, M.S. with long-term industry experience
• Deep and wide technical/scientific knowledge, enabling appropriate application and communication of statistical perspectives
• Experience in the pharmaceutical, animal health, or agricultural science industry is required and should include clinical trial design and analysis as well as demonstrated knowledge of the pharmaceutical/biological life cycle process
• Expertise in particular scientific disciplines related to animal health or pharmaceutical/biological industry is highly desirable
• Demonstrated ability in SAS programming supporting the analysis of data using linear mixed models, generalized linear mixed models, survival and categorical methods; Experience with R is desirable
• Knowledge of statistical theory and application of statistical methodologies in study design and data analysis; sound experience in project management
• Excellent oral and written English communication skills

Additional requirements for Principal Position:

• Demonstrated broad knowledge and experience in planning, transforming, analyzing, interpreting, and reporting from complex clinical trials and projects
• In-depth knowledge and experience regarding advanced statistical concepts as well as relevant software languages
• Advanced project lead experience

• As a Senior Biostatistician, you support the complete clinical life cycle process for infectious disease / noninfectious disease / parasitological animal health products.
• You execute the duties of project and trial statistician for complex studies and provide support that reflects a high level of knowledge.
• You independently drive statistical aspects of clinical study design, with statistical methodologies that support effective and efficient size, conduct, and approval, and analyze clinical study data using SAS or other tools.
• Lead development of statistical analysis plans and TLFs and provide guidance to Statistical Programmers perform statistical analyses.
• Moreover, you will clearly and independently communicate statistical aspects and results of complex clinical trials and related topics for registration, for publication, and for management to ensure appropriate interpretation of results, decision-making, and acceptance for approvals.
• Furthermore, you will ensure regulatory (USDA, CVM, EMA, etc.) requirements and questions regarding Biostatistics are fulfilled.
• In addition, you will also support research studies as requested and perform exploratory analyses and present the results.
• You will apply knowledge of statistics including the ability to interpret current literature relevant to Global Innovation Clinical projects and to influence industry and regulatory agencies in the application of new methodologies.
• Also, you will participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses.Finally, you will oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner.

Additional tasks and responsibilities for Principal Position:

• Support and participate in the development of departmental strategies.
• Cultivate partnerships with internal and external stakeholders and colleagues, provide example and indirect leadership for junior team members, and interact with externals on Biostatistics matters.