Study Design Statistician (Remote)

MMS • Canton Township, MI

40d • Remote

About The Position

MMS is an award-winning, data-focused clinical research organization (CRO) that is Great Place to Work certified and has the industry's best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges. With a global footprint, MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment. This full-time role, with an internal job title of Strategic Statistician, is part of our Strategic Statistical Services Arm. It emphasizes being an internal and external Subject Matter Expert (SME) for clinical trial design, providing consultation on broader statistical issues to clients. Our experienced statisticians and programmers develop intellectual property and assets to support the design and analysis of clinical trials, precision medicine, and real-world data analytics. We address emerging analytics needs with biostatistics services, bespoke algorithms, and proprietary, cloud-based trial simulation software, KerusCloud. Working alongside innovative statisticians, you will lead the full lifecycle of KerusCloud support and statistical services.

Requirements

• Bachelors degree in mathematics, statistics, physics, pharmacology or with a strong statistical component, Masters or PhD preferred.
• 5-7 years of experience in the application of medical statistics (pharma, CRO, academic).
• Willingness to engage with clients to understand and research problems and provide creative, business-orientated solutions.
• Experience in delivering customer projects to high quality standards.
• Experience in SAS and/ or R statistical software packages.

Nice To Haves

• Experience in study design and protocol and report-writing preferred.
• Experience of modelling and simulation techniques to explore complex study designs preferred.
• Experience of Bayesian approaches to design and analysis of clinical data preferred.
• Experience of early-phase drug development processes including innovative/ adaptive study design preferred.

Responsibilities

• Assisting customers with their study design with a particular focus on simulation with KerusCloud to ensure they are aligned with the study objectives.
• Preparation of study protocols and development of Statistical Analysis Plans and Statistical Analysis Reports.
• Summarize, analyze and visualize study data using a variety of statistical methods, ultimately delivering results to an agreed timeline with optimal quality.
• Provide statistical consultancy support to sponsors across the full span of clinical development, including oversight of third-party statistical and programming deliverables.
• Maintain current knowledge of relevant research techniques such as modelling, simulation and experimental design and participate in continuous professional development activity.
• Support pre-sales discussions to understand and identify client needs, then contribute to technical solutions and resource/ cost estimates.
• Collaborate with the Product Development team defining key features and statistical aspects of KerusCloud.
• Provide input and support to Marketing of KerusCloud, including demonstrations to clients, white papers, etc.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior