Principal Scientist, Biostatistics & Data Science

About This Role

At Roche, we believe that every voice matters, and we are committed to fostering a culture where you can truly show up as yourself, embraced for your unique qualities and contributions. Our vibrant and inclusive environment actively encourages personal expression, open dialogue, and the formation of genuine connections. Here, you are valued, accepted, and respected for who you are, enabling you to thrive both personally and professionally. This foundational belief drives our mission to prevent, stop, and cure diseases, ensuring everyone has access to life-changing healthcare today and for generations to come.

We are seeking an exceptionally talented and passionate Principal Scientist in Biostatistics and Data Science to join our dynamic team. This pivotal role offers a unique opportunity to lead the advancement of statistical methodologies and data-driven insights across our diverse drug development pipeline. As a Principal Scientist, you will be at the forefront of leveraging cutting-edge statistical science and innovative data science techniques to accelerate the discovery, development, and delivery of transformative medicines. You will play a crucial role in shaping our research strategies, influencing critical decisions, and ultimately contributing to our overarching goal of improving patient lives globally. This position demands a leader who can not only master complex data challenges but also inspire and mentor others within a collaborative, cross-functional setting.

Key Responsibilities

• Provide expert statistical and data science leadership for clinical trials, real-world evidence studies, and exploratory research initiatives across various therapeutic areas.
• Design, develop, and implement advanced statistical methodologies and innovative data science approaches, including machine learning and artificial intelligence, to extract meaningful insights from complex biological and clinical data.
• Lead the statistical design, sample size determination, and analysis planning for pivotal studies, ensuring scientific rigor and regulatory compliance.
• Oversee the execution of statistical analyses, interpret results, and communicate findings effectively to cross-functional teams, senior leadership, and external stakeholders.
• Drive the development and validation of predictive models, biomarkers, and patient stratification strategies to enhance precision medicine initiatives.
• Collaborate closely with clinical development, regulatory affairs, medical affairs, and research scientists to integrate statistical and data science perspectives into all stages of drug development.
• Contribute to regulatory submissions (e.g., FDA, EMA) by preparing statistical sections of protocols, reports, and responses to agency queries.
• Mentor and guide junior statisticians and data scientists, fostering a culture of continuous learning, innovation, and scientific excellence within the department.
• Stay abreast of emerging statistical and data science methodologies, software, and industry best practices, proactively identifying opportunities for their application within Roche.
• Publish and present scientific work at internal and external conferences, contributing to the broader scientific community.

Requirements & Qualifications

• Ph.D. in Biostatistics, Statistics, Data Science, or a closely related quantitative field.
• A minimum of 8-10 years of progressive experience in biostatistics and data science within the pharmaceutical, biotechnology, or a highly regulated healthcare industry setting.
• Demonstrated expertise in the design, analysis, and interpretation of clinical trials (Phase I-IV) and observational studies.
• Profound understanding of advanced statistical modeling techniques, Bayesian methods, and causal inference.
• Strong proficiency in statistical programming languages such as R, SAS, and Python, including experience with relevant data science libraries and tools.
• Extensive experience with real-world data (RWD) and real-world evidence (RWE) generation and analysis.
• Proven ability to lead projects, manage timelines, and deliver high-quality statistical and data science solutions in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to convey complex quantitative concepts to diverse audiences.
• Demonstrated leadership capabilities, including mentoring, influencing, and fostering collaboration across multidisciplinary teams.
• Prior experience interacting with regulatory authorities and contributing to regulatory submissions is highly desirable.

Skills & Competencies

• Biostatistics
• Statistical Modeling
• Clinical Trial Design & Analysis
• Data Science
• Machine Learning
• R, SAS, Python Programming
• Leadership & Mentorship
• Scientific Communication

What We Offer

Joining Roche means becoming part of a global leader in healthcare, dedicated to groundbreaking science and patient-centric innovation. Beyond a challenging and rewarding career, you will find a supportive and inclusive culture that values your unique perspective and encourages continuous growth. As part of our commitment to enabling you to thrive both personally and professionally, Roche offers a comprehensive rewards package designed to support your well-being and professional aspirations. While specific details can be discussed during the interview process, we are proud to provide a competitive compensation structure, opportunities for professional development, and a work environment where every voice truly matters.

• Opportunity to make a significant impact on global health outcomes
• Collaborative and inclusive work environment
• Professional development and continuous learning opportunities
• Competitive compensation
• Comprehensive benefits (details available upon inquiry)

How to Apply

If you are a visionary Principal Scientist with a passion for leveraging statistics and data science to transform patient care, and you are eager to contribute to a company dedicated to scientific excellence and a supportive culture, we encourage you to apply. Join Roche, where your expertise will help us prevent, stop, and cure diseases for generations to come. Please submit your application through our career portal, including your detailed resume and a cover letter outlining your relevant experience and why you are the ideal candidate for this role.