Senior Principal Biostatistician

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role At the intersection of clinical science, data innovation, and drug development, this role offers a rare opportunity to shape the statistical foundation of life-changing medicines. As a Senior Principal Biostatistician within the Global Biostatistics team, you will serve as a Statistical Subject Matter Expert at the Global or Regional Program study team level, designing, analyzing, and interpreting data from clinical and observational studies with a high degree of autonomy. From early development through regulatory submission and lifecycle management, your work will directly influence the scientific integrity and success of clinical programs that matter to patients worldwide. You will act as statistical subject master expert to collaborate with cross functional teams to contribute to study design, establishing objectives, endpoints, and estimands while evaluating designs through advanced simulations. You will develop and maintain strategic analysis plans, author Statistical Analysis Plans (SAPs) and statistical sections of Clinical Study Reports (CSRs), and perform or oversee statistical analyses across multiple trials, including complex data from biomarkers, genomics, real-world evidence, patient-reported outcomes, digital devices, and imaging. You will also support regulatory submissions by contributing to the integrated safety and efficacy summary statistical analyses ensuring alignment with ICH, FDA, EMA, and regional guidelines. Beyond your technical contributions, you will drive innovation within the department by critically appraising and applying emerging technologies, including machine learning, artificial intelligence, and large language models in statistical contexts, and by contributing to business development activities through statistical expertise. Who You Are Basic / Minimum Qualifications: Master’s degree in a Data Sciences discipline, such as Statistics, Biostatistics, Informatics, Bioinformatics, Mathematics, or Computer Science, with at least 5 years of experience in pharmaceutical or biotechnology clinical development; OR a doctoral degree in a Data Sciences discipline with at least 3 years of equivalent industry experience. 3+ years of hands‑on programming experience in SAS or R within a clinical development environment. Educated in ICH and Good Clinical Practice (GCP) guidelines, with the ability to navigate additional relevant regulatory frameworks (FDA, EMA, and regional authorities). Demonstrated ability to apply advanced statistical methods, including missing data strategies, multiple testing, and complex endpoint modeling, in drug development or related research. Preferred Qualifications: Deep understanding of the biological, genetic, and systemic background of assigned clinical therapeutic areas. Experience overseeing vendors and Contract Research Organizations (CROs) in a statistical capacity. Familiarity with the critical appraisal and responsible application of machine learning, artificial intelligence, and large language model technologies within biostatistics, including awareness of their limitations, ethical considerations, and governance implications. Strong communication skills with the ability to present complex statistical concepts clearly to cross‑functional stakeholders, including senior leadership. Base Pay Range for this position – $122,700 - $184,100 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job‑related factors. Position may be eligible for sales or performance‑based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! #J-18808-Ljbffr Biopharma Careers