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 expert in 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 Reports.
• 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 and engage in continuous professional development.
• Contribute to pre-sales discussions by understanding client needs and contributing to technical solutions and resource/cost estimates.
• Collaborate with the Product Development team to define key features and statistical aspects of KerusCloud.
• Support the marketing of KerusCloud through demonstrations, 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, especially for complex study designs.
• Experience with Bayesian approaches to clinical data design and analysis.
• Experience with early-phase drug development processes, including innovative/adaptive study design.