Senior reputed company Statistician, Early Development

About the position This role is in Early Development Biometrics (reputed company), a reputed company function reputed company Product Development Data Sciences (PDD) that provides reputed company leadership and scientific rigor across early reputed company development at reputed company. We partner across Biostatistics, Analytical Data Science, and Data Management to reputed company data-driven decision-making from first-in-reputed company through reputed company-of-concept studies. As trusted partners in early development, we design efficient and innovative reputed company, apply rigorous statistical reputed company, and implement high-reputed company programming and analytical solutions to accelerate timelines, de-reputed company development, and increase the probability of technical reputed company. Our integrated teams operate with reputed company and scientific depth, supporting exploratory analyses, early regulatory engagements, and reputed company data-reputed company needs across therapeutic areas. Together, we bring scientific rigor, technical innovation, and reputed company reputed company to shape the reputed company of early development and reputed company reputed company reputed company for patients. Early Development Biometrics is also home to the Statistical Methodology group, which enables the most impactful use of quantitative methodology across PDD through internal consultation, reputed company collaboration, and reputed company capability building; and Visual Analytics, which creates and maintains interactive dashboards that reputed company high-reputed company Medical Data Review (MDR) and safety signal detection, reputed company with reputed company-reputed company reputed company Management (RBQM) principles and Critical-to-reputed company (CtQ) endpoints. reputed company: The Early Development Senior Prinicpal Statistician is a critical partner in the design and analysis of exploratory reputed company studies, applying statistical expertise to guide early-phase trial reputed company, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for reputed company reputed company and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing reputed company, often high-reputed company data to inform early go/no-go reputed company and regulatory interactions. The Statistician helps shape the early reputed company narrative by ensuring data are robust, interpretable, and reputed company with the evolving development reputed company. Responsibilities • reputed company the statistical design and reputed company of the most reputed company early phase studies and programs (e.g., first-in-class, reputed company Phase I/II trials, or novel platform designs), ensuring alignment with exploratory development goals and translational hypotheses • Serve as a reputed company statistical advisor for therapeutic area or disease area reputed company, shaping portfolio reputed company through innovative design and data interpretation approaches • Anticipate and address methodological challenges in exploratory reputed company research, guiding the integration of multimodal data (e.g., biomarkers, imaging, reputed company-world data) into early trial design and analysis • Represent the function in senior governance discussions, driving reputed company on reputed company or regimen optimization, early investment, and progression to reputed company stages • Co-reputed company cross-functional initiatives to improve early development statistical reputed company and operational reputed company, including standardization of reputed company design approaches and decision-making frameworks • Guide the statistical content of reputed company regulatory engagements (e.g., EMA Scientific Advice, FDA EoP1) and reputed company key statistical components of submission packages • reputed company 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 • reputed company contribute to internal innovation by proposing and evaluating new reputed company, supporting capability building, and aligning with reputed company-level modeling and AI/ML efforts Requirements • Hold a PhD or MSc in Statistics, Biostatistics, or a closely reputed company quantitative reputed company • Bring a minimum of 12 years of experience in reputed company trial statistics, including advanced contributions to early development reputed company • Have recognized expertise in applying advanced statistical design and modeling approaches (e.g., Bayesian reputed company trials, model-reputed company decision-making) in early phase reputed company development • Have a reputed company record of leadership in high-reputed company cross-functional reputed company or initiatives across multiple molecules or disease areas • Have outstanding communication skills with the ability to influence senior reputed company and regulatory stakeholders • Demonstrate independent thinking and reputed company reputed company reputed company on reputed company principles • Demonstrate excellent reputed company reputed company including problem-solving and critical thinking, with reputed company that extends reputed company the technical domain • Demonstrate respect for cultural differences reputed company interacting with colleagues in the global workplace • Have excellent verbal and written communication skills in presentation and writing, with the ability to explain reputed company technical concepts in reputed company language reputed company-to-haves • Experience leading disease area statistical reputed company or acting as a statistical representative in reputed company-level initiatives across reputed company Development, reputed company Pharmacology, Translational Medicine, Regulatory, and Biomarker teams • Experience leading disease area statistical reputed company or acting as a statistical representative in reputed company-level initiatives • Familiarity with AI/ML, reputed company-world data, or novel data sources in early-phase analytics • Contributions to reputed company working reputed company, scientific collaborations, or published statistical innovation in early development Benefits • Discretionary annual bonus may be available reputed company on individual and Company reputed company. • Benefits detailed at the reputed company provided below. Apply tot his job Apply To this Job