Principal / Senior Clinical Biostatistician - Remote

W.L. Gore & Associates-posted 6 months ago

Full-time • Senior

Remote • Flagstaff, AZ

Miscellaneous Manufacturing

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We are looking for a Senior/Principal-level Clinical Biostatistician to join our medical team. In this role, you will operate as a strategic partner and subject matter expert, contributing to Gore medical device products throughout both pre-launch and post-launch phases, including real-world evidence (RWE) generation. This is a remote position, and you can work from home in most locations within the United States.

Provide statistical expertise in statistical strategy and study design
Contribute to the development of protocol, including not limited to statistical sections and development of the statistical analysis plan
Contribute to the development of case report form aligned with study objectives and data collection standard
Contribute to various clinical activities including AERT, DSMB, DMCs, CECs, and regulatory reporting
Conduct simple and simulation-based sample size and power calculations in various study settings, including clinical trials and observational studies
Conduct statistical analyses on safety and efficacy endpoints in clinical trials and real-world studies
Provide statistical support for publications, presentations, and marketing efforts
Participate in the organization and preparation of regulatory submissions, as well as other study summary documents for internal and external purposes
Communicate with scientists, engineers, and clinicians, both internally and externally, as well as regulatory agencies including the FDA, PMDA, NMPA, and EMA, and support regulatory submissions such PMA, PMS, IDE, PRE-submission ensuring compliance with industry standards
Lead biostatistics continuous improvement initiatives

Master's degree and minimum 5 years experience or PhD and minimum 2 years of industry experience in biostatistics, epidemiology, or related field, with a strong understanding of regulatory requirements
Biostatistics experience in a clinical trial and real-world evidence (RWE) environment
Experience supporting regulatory submissions such as PMA, PMS, IDE, pre-submissions, ensuring compliance with industry standards
Experience working on cross-functional teams
Competent in SAS systems and programming in R
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint)
Organizational skills, flexibility, and ability to multi-task
Strong English verbal and written communication skills

In-depth expertise in theoretical and applied biostatistics, particularly in the fields of clinical trials, clinical epidemiology and RWE methodologies
Experience supporting clinical studies that leverage clinical trials with data from post-approval studies and real-world data sources using Bayesian and RWE methodologies
Expertise in causal inference techniques including propensity score matching/IPTW/subclassification, matching-adjusted indirect comparisons, simulation treatment comparisons, network meta-analysis, doubly robust estimation, G-computation, and marginal structural models

Comprehensive and competitive total rewards program
Choice and flexibility in benefits promoting overall well-being
Distinctive Associate Stock Ownership Plan
Potential opportunities for profit-sharing

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Principal / Senior Clinical Biostatistician - Remote

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