W. L. Gore & Associates, Inc.
Clinical Biostatistician
W. L. Gore & Associates, Inc., Newark, Delaware, United States, 19711
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 (RWE) generation. This is a remote position, and you can work from home in most locations within 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 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
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 (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
Desired Qualifications
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.
What We 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 tomorrow. 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, 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. All 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 all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.
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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 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
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 (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
Desired Qualifications
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.
What We 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 tomorrow. 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, 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. All 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 all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.
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