Study Design Statistician (US)

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As part of our Biometrics Strategic Consulting Arm, this is a full-time role with emphasis on being an internal SME for clinical trial design, together with advising clients on a range of broader statistical issues, and will have an internal job title of Consultant Statistician.

Job Description:

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 the emerging analytics needs of the Industry with our biostatistics services, bespoke algorithms and unique, state of the art, proprietary, cloud-based trial simulation software KerusCloud. Working alongside innovative statisticians you will be responsible for leading the full life-cycle of KerusCloud support and statistical services, from:

• 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.

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.
• 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.