Apply on Employer Site

W. L. Gore & Associates · 1 day ago

Clinical Biostatistician

United States

Full-time

Remote

Senior Level, Lead/Staff

5+ years exp

W. L. Gore & Associates is seeking a Senior/Principal-level Clinical Biostatistician to join their medical team. The role involves providing statistical expertise and contributing to clinical activities related to medical device products throughout pre-launch and post-launch phases, including real-world evidence generation.

Health CareManufacturingMedical Device

No H1B

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

Qualification

BiostatisticsClinical trialsReal-world evidence (RWE)SASRStatistical analysisCommunication skillsOrganizational skillsTeam collaboration

Required

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

Preferred

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