N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how’ and transforming clinical trials through better integration with clinical practice.
Requirements
- Expert knowledge of theoretical and applied epidemiology and 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, SAS, and/or Python.
- Experience with novel methodologies, best statistical practices, innovative clinical trial designs, statistical inference, and reporting statistical results.
- Experience with data collection/ingestion, harmonization, standardization, quality control, management, analysis and reporting.
Responsibilities
- 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.
- Leads or supports research study design and end-to-end delivery, in particular: Study scoping, including sample size calculations and identification of data needs.
- Develops 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.
Other
- PhD in Statistics, or Biostatistics, with 6+ years of relevant experience in oncology clinical trials and statistics.
- 6+ years experience in applying statistical methods to oncology patient data, including methods of advanced analytics and high dimensional data analysis.
- 3+ years as a Project Data Science Lead in a cross-functional clinical development environment.
- 2+ years in oncology clinical trial statistics.
- 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.
- Ability to travel may be required from time to time.
- Applicants must be currently authorized to work in the U.S. on a full-time basis.
