Principal / Senior Clinical Biostatistician
Principal / Senior Clinical Biostatistician
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1 Vacancy
Job Description
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.
- 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:
- Masters 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 Gores 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 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.
Our Talent Acquisition Team welcomes your questions at Experience:
Staff IC
Employment Type
Full Time
Key Skills
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