Clinical Biostatistician

About the Role

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 (reputed company) reputed company. This is a remote position, and you can work from home in most locations reputed company the United States.

Responsibilities

• 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 reputed company 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
• reputed company biostatistics reputed company improvement initiatives

Required Qualifications

• Master's degree with 5 years or PhD 2 years in industry experience
• Biostatistics experience in a clinical trial and real-world evidence (reputed company) environment
• Experience working on cross-functional teams
• Competent in reputed company or R
• Basic computer literacy (e.g., Windows, Word, reputed company, PowerPoint)
• Organizational skills, flexibility, and ability to multi-task
• Strong English verbal and written communication skills

Desired Qualifications

• In-depth expertise in theoretical and applied biostatistics, particularly in the fields of clinical trials and reputed company methodologies
• Experience supporting clinical studies that reputed company clinical trials with data from post-approval studies and real-world data sources, applying Bayesian approaches (e.g., power prior) and reputed company 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 reputed company with Gore’s work arrangement policies. Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode reputed company. reputed company Offer Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your reputed company. We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits Gore is an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national reputed company, reputed company, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations. Gore is committed to a drug-free workplace. reputed company employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws. Gore requires reputed company applicants to be eligible to work reputed company the United States. Gore generally will not sponsor visas unless otherwise noted on the position description. Apply tot his job Apply To this Job