Senior Staff Biostatistician jobs in United States
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N-Power Medicine, Inc. · 7 hours ago

Senior Staff Biostatistician

N-Power Medicine is focused on transforming clinical trials and drug development through better integration with clinical practices. The Senior Staff Biostatistician will lead the Quantitative Sciences team in developing rigorous statistical designs and analyses, collaborating with multidisciplinary teams to enhance oncology clinical development.

BiotechnologyClinical TrialsPharmaceutical
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Responsibilities

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
Perform additional duties and responsibilities as required

Qualification

PhD in StatisticsExpert knowledge of statisticsExternally controlled studiesProgramming in RProgramming in PythonStatistical consulting skillsEntrepreneurial spiritGenerousCuriousHumbleProject management skillsCollaboration skills

Required

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

Benefits

Equity at hire
Discretionary annual bonus
Company benefits
401K plan
Other great company “perks”

Company

N-Power Medicine, Inc.

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N-Power Medicine is developing a radically faster, smarter paradigm for drug development that enables biopharma to move beyond traditional randomized clinical trials.

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
Merck Global Health Innovation Fund
2024-05-21Series B

Leadership Team

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Mark Lee
CEO & Co-Founder
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Company data provided by crunchbase