Study Design Statistician (US)
Posted 18 days ago
mms holdingsIndianapolis (IN)
StatisticiansOther Scientific and Technical Consulting Services
SENIORITY
Senior
About the role
As part of our Strategic Statistical Services Arm: This full‑time role emphasizes being an internal and external SME for clinical trial design, providing consultation to advise clients on a range of statistical issues. The internal job title is Strategic Statistician.
Job Description
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.
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