Principal / Senior Clinical Biostatistician - Remote

W. L. Gore & Associates, Inc.; Flagstaff (AZ); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company in medical devices is seeking a Senior/Principal Clinical Biostatistician. This remote role requires providing statistical expertise in clinical trials and real-world evidence, with opportunities to support regulatory submissions. Candidates should possess a Master's or PhD in Biostatistics and relevant experience. The company promotes a diverse and inclusive workplace with a competitive rewards program.

Benefits

Comprehensive and competitive rewards program

Associate Stock Ownership Plan

Profit-sharing opportunities

Qualifications

• Master’s degree and minimum 5 years experience or PhD and minimum 2 years of industry experience.
• Biostatistics experience in a clinical trial and RWE environment.
• Competent in SAS systems and programming in R.

Responsibilities

• Provide statistical expertise in statistical strategy and study design.
• Conduct statistical analyses on safety and efficacy endpoints in clinical trials.
• Lead biostatistics continuous improvement initiatives.

Skills

Statistical expertise

Regulatory knowledge

Communication skills

Organizational skills

Education

Master’s degree or PhD in Biostatistics, Epidemiology, or a related field

Tools

SAS

R

Windows

Excel

Word

PowerPoint

Job description

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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 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

Required Qualifications:

• 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
• Ability to travel up to 5%

Desired Qualifications:

• 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

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).

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

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Gore is an equal opportunity employer. We welcome all applications irrespective of 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 covered 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 U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.

Copyright 2024 W. L. Gore & Associates, Inc.