npowermedicine - N-Power Medicine - Sr. Staff, Quantitative Sciences

• In collaboration with QS leaders, builds expert capabilities in prospective ECAs and hybrid controls combining retrospective and prospective real world-data with single arm and randomized controlled trials. • Provides expertise for developing statistical methodologies that mitigate, observed and unobserved, selection, confounding, and measurement bias in external control and hybrid control studies utilizing retrospective and prospective observational data. • Guides and mentors internal teams on novel methodologies, best statistical practices, innovative clinical trial designs, statistical inference, and reporting statistical results. • Collaborates with Clinical Science and Commercial teams to provide statistical leadership for innovative clinical development projects, including providing strategic input into clinical study plans and protocols, regulatory strategy, target product profiles (TPPs), and integrated evidence plans. • Collaborates with the Data and Technology cross functional partners to define data requirements and data collections processes to enable next generation ECAs. • Leads or supports research study design and end-to-end delivery, in particular: • -Study scoping, including sample size calculations and identification of data needs. • -Design elements, and approach to bias mitigation in the design and analysis phases. • -Development of study protocols and statistical analysis plans. • -Leads or supports the execution of the analysis plan, including the development of adjacent algorithms and other scalable tools. • -Leads the communication of novel methodology developed in the course of the study. Co-authors communications of study results in peer-reviewed publications, presentations, and health authority reports. • Participates in internal, cross-functional discussions on data and platform strategy, and workflow development. • Champions the development of tools, algorithms, and robust pipelines in support of study delivery, product offerings, data improvements, and efficiency, scalability, and reproducibility increases. • Education, Experience, Behavioral Competencies, & Skills • 5+ years of industry/research experience or equivalent experience. • PhD in Statistics, or Biostatistics, or Related Field. • Expert knowledge of theoretical and applied statistics, including inferential methods for time-to-event analysis, survival analysis, and causal inference methods. • Expertise in design and analysis of externally controlled studies and hybrid controls including propensity score methods, endpoint measurement bias correction methods, and external patient borrowing bayesian and frequentest methods. • Fundamental understanding of clinical- and efficacy endpoints used in oncology development. • Experience collaborating with clinical-, biomarker-, and imaging scientists, to apply statistical methods to oncology drug development. • Extensive experience with programming in R and/or Python. • Strong communication and collaboration skills (including statistical consulting skills, and interpersonal skills). • Ability to work and collaborate in a fast paced, start-up environment. • Entrepreneurial, credible and creative spirit capable of influencing stakeholders to advance the use of ECAs to inform Go no-Go and regulatory decisions. • Excellent project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors). • Excellent and autonomous drive for results (e.g., demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges, proactively finds solutions to technical problems). • Generous, Curious and Humble.