Principal Biostatistician

The Opportunity: The Statistician is a key member of the cross-functional study or molecule team, responsible for applying statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. This role ensures the scientific rigor and regulatory compliance of the study by contributing to protocol development, authoring statistical analysis plans, performing or overseeing data analyses, and supporting the interpretation and communication of results. The Statistician plays a critical role in ensuring that each study generates robust, meaningful data to support decision-making and regulatory submissions. You are accountable for strategy and execution of all statistical aspects of a molecule program You ensure the application of digital, design, and data capabilities at the molecule program level You represent PDD on cross-functional teams, such as the Development and Lifecycle Team You ensure consistency, scientific rigor, and regulatory readiness of statistical deliverables, including protocols, statistical analysis plans, outputs, and submissions You contribute to internal and external scientific communication, including publications, presentations, and engagement with methodological communities You lead statistical design for complex or priority studies, introducing innovative methodologies You ensure strategic alignment and quality across statistical deliverables in programs or submissions You solve complex statistical challenges using deep expertise and novel approaches You represent the function in strategic cross-functional teams, discussions, and decision-making forum You interpret and drive the narrative of key results for internal and external stakeholders You own statistical content in major regulatory submissions, ensuring integrity and clarity You lead sub-streams or functional contributions in global or large-scale cross-functional initiatives You mentor junior staff Who You Are You hold a PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field You have 6+ years of experience in clinical trial statistics, including responsibility for study-level strategy and decision-making You have a proven ability to lead statistical input into clinical development plans and regulatory submissions You bring strong expertise in applying advanced statistical methods to support data-driven decision-making You are proficient in SAS and/or R with deep familiarity with CDISC standards and evolving regulatory data requirements You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles You bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain You demonstrate respect for cultural differences when interacting with colleagues in the global workplace You have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear language You are able to effectively partner with stakeholders within and outside of PDD Preferred: Experience working in cross-functional global study teams Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences Experience with multiple phases of drug development (early and/or late stage) Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders Experience in mentoring or scientific leadership within a matrix organization Strategic mindset with the ability to contribute to portfolio-level decisions Must have : 5+ years’ experience in Biostatistics & SAS Experience with Late Phase Independent trial statistician experience Would be good to have R