Senior/Principal Statistician for Healthy Volunteer Studies

Senior or Principal Clinical Data Scientist The Position Join a team where your expertise drives meaningful scientific progress! In Global Experimental Medicine, we drive forward innovative therapeutic concepts and drug candidates that offer clear benefits for patients. With speed and precision, we strive to achieve early patient proof of concepts (PoCs) by combining our strengths and acting with urgency. In the Data & Analysis Department within Experimental Medicine, we focus on delivering high quality clinical data efficiently and supporting modern, innovative study designs and their respective analyses, enabling transparent insights that strengthen informed decision making. We encourage you to bring your expertise as a Senior or Principal Statistician for Healthy Volunteer Studies for clinical pharmacology trials and play a key role in shaping the future of clinical development within Experimental Medicine. In this position, you will support clinical drug development by providing strategic planning and execution of our clinical trials as well as all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data. Ready to shape the future of Experimental Medicine? Apply now. This position can be filled in Ingelheim or Biberach. This position has a hybrid setup with approximately 1-2 days per week on site. This position can be filled either as Senior Statistician or Principal Statistician. Tasks & responsibilities As a Senior Statistician, you will be responsible for the planning and execution of clinical pharmacology trials such as first in human SRD/MRD, bioequivalence, bioavailability, special populations, drug–drug interaction, hADME and TQT. Furthermore, you will oversee all aspects of data analytics, developing statistical study designs and statistical analysis plans, and provide the necessary analytical tools and outputs to support high-quality trial delivery. You will apply established statistical methodologies and integrate innovative data science approaches to design studies and analyze clinical data from clinical pharmacology trials generating insights that ultimately help us make a meaningful difference for our patients. In addition, you will work closely with colleagues from various disciplines across Experimental Medicine and Medicine, providing statistical expertise to support clinical pharmacology trials. You will enhance your business knowledge and scientific expertise in a global drug development environment. Moreover, with your expertise you will exchange with the statistical and data science community inside and outside of Boehringer Ingelheim. Additional tasks for a Principal Position As a Principal Statistician, you will additionally lead and oversee the design, analysis, and reporting of complex clinical pharmacology trials. You will lead and guide colleagues as well as internal and external partners on statistics and data science–related tasks. Requirements Master of Science (MSc) in Statistics or Mathematics or comparable with several years’ experience in drug development, including sound knowledge of statistical methodology, design of clinical pharmacology trials, basic medical terminology, and processing clinical trial information Advanced knowledge of and hands‑on experience in relevant software languages, like SAS and R Familiarity with submission standards such as CDISC, FDA, EMA guidelines and regulatory requirements for clinical data analysis Ability to proactively identify issues and solutions as well as to interact with internal and external bodies on routine data science issues Strong interpersonal skills for effective collaboration within and outside of our organization, including a “We” mindset, empathy, trust‑building, curiosity, courage and a consistent big picture mindset Oral and written communication skills to interact in interdisciplinary teams as well as the ability to explain, visualize and communicate statistical information to non‑statisticians effectively Fluency in written and spoken English Doctoral Degree (PhD) with several years of relevant professional experience or master’s degree with longstanding relevant professional experience Broad knowledge and advanced experience in complex clinical pharmacology trial designs, trial development processes, and corresponding data analyses In depth understanding of advanced statistical concepts relevant to clinical pharmacology trials As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process. We also offer a comprehensive benefits and wellbeing package. Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process. #J-18808-Ljbffr Boehringer Ingelheim GmbH