Senior Principal Statistician, Early Development at F. Hoffmann-La Roche Ltd - Poland

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

0.0

Posted On

22 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Design, Data Analysis, Protocol Design, Statistical Analysis Plans, High-Dimensional Data, Bayesian Adaptive Trials, Model-Based Decision-Making, AI/ML, Real-World Data, Regulatory Strategy, Data Interpretation, Cross-Functional Leadership, Scientific Rigor, Technical Innovation, Strategic Insight, Data Management

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position This role is in Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across early clinical development at Roche. We partner across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decision-making from first-in-human through proof-of-concept studies. As trusted partners in early development, we design efficient and innovative clinical trials, apply rigorous statistical methods, and implement high-quality programming and analytical solutions to accelerate timelines, de-risk development, and increase the probability of technical success. Our integrated teams operate with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data-generation needs across therapeutic areas. Together, we bring scientific rigor, technical innovation, and strategic insight to shape the future of early development and deliver better outcomes for patients. Early Development Biometrics is also home to Methods Collaboration & Outreach (MCO), which enables the most impactful use of quantitative methodology across PDD through internal consultation, external collaboration, and continuous capability building; and Visual Analytics, which creates and maintains interactive dashboards that drive high-quality Medical Data Review (MDR) and safety signal detection, aligned with Risk-Based Quality Management (RBQM) principles and Critical-to-Quality (CtQ) endpoints. The Opportunity The Early Development Statistician is a critical partner in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions. The Statistician helps shape the early clinical narrative by ensuring data are robust, interpretable, and aligned with the evolving development strategy. You lead the statistical design and strategy of the most complex early phase studies and programs (e.g., first-in-class, seamless Phase I/II trials, or novel platform designs), ensuring alignment with exploratory development goals and translational hypotheses You serve as a primary statistical advisor for therapeutic area or disease area strategy, shaping portfolio decisions through innovative design and data interpretation approaches You anticipate and address methodological challenges in exploratory clinical research, guiding the integration of multimodal data (e.g., biomarkers, imaging, real-world data) into early trial design and analysis You represent the function in senior governance discussions, driving decisions on dose or regimen optimization, early investment, and progression to later stages You co lead cross functional initiatives to improve early development statistical strategy and operational excellence, including standardization of adaptive design approaches and decision-making frameworks You guide the statistical content of strategic regulatory engagements (e.g., EMA Scientific Advice, FDA EoP1) and author key statistical components of submission packages You provide technical leadership to statisticians and cross-functional colleagues, acting as a recognized expert in early development design and a senior advisor across studies or therapeutic area teams You actively contribute to internal innovation by proposing and evaluating new methods, supporting capability building, and aligning with enterprise-level modeling and AI/ML efforts Who you are You hold a PhD or MSc in Statistics or Biostatistics, backed by at least 12 years of experience in clinical trial statistics and a deep focus on early development strategy. You possess recognized expertise in advanced statistical design—such as Bayesian adaptive trials and model-based decision-making—and bring a forward-thinking interest in AI/ML and real-world data applications. You are a proven leader who has steered high-impact, cross-functional projects across multiple disease areas, often acting as a key statistical representative for enterprise-level initiatives. You command outstanding communication and influence, with the ability to translate complex technical concepts into clear, actionable insights for senior clinical, regulatory, and global stakeholders. You demonstrate exceptional strategic agility and independent decision-making, applying sound principles and critical thinking to solve problems far beyond the purely technical domain. You are an active contributor to the broader scientific community through external collaborations, working groups, or published innovations, all while maintaining a high degree of cultural respect in a global workspace. Scientific rigour and creativity, inclusive teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative. If you are passionate about contributing to a committed team and have the dedication to partnership and innovation, Roche is the place for you! Every role at Roche plays a part in making a difference in patients’ lives. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Responsibilities

The Senior Principal Statistician leads the statistical design and strategy for complex early-phase clinical studies, serving as a primary statistical advisor for therapeutic area strategy and shaping portfolio decisions. Responsibilities include guiding regulatory engagements, authoring key statistical components of submission packages, and providing technical leadership to other statisticians.