Study Design Statistician (US)

About the role

This is a full-time role within MMS's Strategic Statistical Services Arm. The primary focus is to serve as an internal and external SME for clinical trial design, while also providing consultation on broader statistical issues.

Responsibilities

• Assist customers with study design, particularly focusing on simulation with KerusCloud to align with study objectives.
• Prepare study protocols and develop Statistical Analysis Plans and Statistical Analysis Reports.
• Summarize, analyze, and visualize study data using various statistical methods, ensuring timely delivery of results of optimal quality.
• Provide statistical consultancy support throughout the clinical development process, including oversight of third-party deliverables.
• Maintain up-to-date knowledge of relevant research techniques such as modeling, simulation, and experimental design, and engage in continuous professional development.
• Support pre-sales activities by understanding client needs, contributing to technical solutions, and preparing cost estimates.
• Collaborate with the Product Development team to define key features and statistical aspects of KerusCloud.
• Contribute to marketing efforts for KerusCloud, including demonstrations to clients, white papers, and other promotional materials.

Requirements

• Bachelor’s degree in mathematics, statistics, physics, or a related field with a strong statistical component, Master’s or PhD preferred.
• 5-7 years of experience in medical statistics, preferably in pharma, CRO, or academia.
• Willingness to engage with clients to understand and solve complex problems creatively and business-orientedly.
• Experience in delivering high-quality customer projects.
• Experience with SAS and/or R statistical software packages.
• Experience in study design, protocol writing, and report preparation.
• Experience with modeling and simulation techniques to explore complex study designs.
• Experience with Bayesian approaches to design and analysis of clinical data.
• Experience with early-phase drug development processes, including innovative/adaptive study design.