Senior Non-Clinical Statistician

  • Boehringer Ingelheim
  • Ingelheim am Rhein, Germany
  • 04/10/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics Data Governance

Job Description

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION

This position is an active part of the network of non-clinical statisticians and has input on projects on other sites with support and alignment of the Principal Statistician. You represent BI at a regional level such as supporting Regulatory Affairs to prepare the industry position on methodologies and analysis related to our products. By using new and existing methodologies you have impact on program decisions and help achieve goals and milestones.


Tasks & responsibilities

  • As the Senior Non-Clinical Statistician (NCS), you provide statistical designs and analyses that contribute to core group/research goals and reflect expert knowledge.
  • You identify and implement new statistical methodologies that support more effective and efficient study conduct and approval. You are responsible for statistical reports that meet regulatory requirements for submission to the agencies.
  • As representative in multiple project teams you contribute to defining statistical related aspects of overall program goals and convey analysis to Technical Development Leaders, scientists, and Regulatory Affairs.
  • Independently, you prepare clear technical reports, oral presentations and communicate results in for the form of complete documentation. Upon request, contributes and presents project related topics within Regulatory forums (FDA/USDA).
  • Furthermore, you develop visibility outside of functional area and effectively interacts scientifically. You liaise internally with cross-functional stakeholders to communicate and align expectations. Also, you demonstrate ability to interpret current literature and convey relevance to development projects.
  • Thanks to your interpersonal skills, you easily develop sound personal relationships and partnerships within the statistics group, across multiple functions within BI, and applicable regulatory forums.
  • You engage and collaborate with NCS network to share best practices. Also, you develop and provide on-site training for non-statisticians.


Requirements

  • Ph. D. in statistics, biostatistics, or mathematics with sound statistical theory and application of relevant methodologies in study design and analysis with several years of nonclinical statistical focus in the pharmaceutical/biological industry and/or Regulatory Authorities. Alternatively, M.S. in the above-mentioned areas with long-term industry experience
  • Knowledge of statistical methodology and its application to lab sciences in biologics and/or pharmaceutical development
  • Relevant statistical software programs for data management, analytics, multivariate analysis, and predictive analysis
  • Solid understanding of cGMP guidelines
  • Ability to write statistical aspects of study protocols, study reports, and publications
  • Excellent interpersonal skills to interact with different stakeholders (regulatory affairs, project leaders, and lab leaders, etc.) on statistical issues
  • Ability to work effectively as part of a team and manage project from a statistical perspective
  • Excellent oral and written English and German communication skills


EFFECTS OF COVID-19


We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.


WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.
Want to learn more about us? Visit https://www.boehringer-ingelheim.com/
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.
READY TO CONTACT US?


Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173
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Job - Research & DevelopmentPrimary Location - Europe-DE-Rhinland-Palatinate-IngelheimOrganization - DE-Boehringer Ingelheim Vetmedica GmbH (Germany)Schedule - Full-time