Clinical Biostatistician

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 standards
• 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
• Lead biostatistics continuous improvement initiatives

• Master's degree with 5 years or PhD 2 years in industry experience
• Biostatistics experience in a clinical trialand real-world evidence (RWE) environment
• Experience working on cross-functional teams
• Competent in SAS or 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 and RWE methodologies
• Experience supporting clinical studies that leverage clinical trials with data from post-approval studies and real-world data sources, applying Bayesian approaches (e.g., power prior) and RWE methodologies (e.g., propensity score matching, inverse probability of treatment weighting, doubly robust estimation)
• Specialized knowledge in group sequential designs and Bayesian adaptive designs

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.