Study Design Statistician

🕒 April 21

🚗 Michigan – Remote

🚗 Michigan – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✍️ Designer

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MMS

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

💰 Private Equity Round on 2022-06

Pharmaceuticals • Biotechnology • SaaS

MMS is a leading data-focused Contract Research Organization (CRO) specializing in pharmaceutical and biotechnology innovation. With a strong emphasis on regulatory expertise and technological innovation, MMS provides a comprehensive range of services including regulatory submissions, data management, biostatistics support, medical writing, and pharmacovigilance. The company is known for its AI and technology-driven platforms like Datacise®, PVantage®, and Automatiqc®, which enhance efficiency and streamline clinical trial processes. MMS supports its clients from the investigational new drug application phase through to marketing authorization and post-approval, offering integrated solutions to accelerate drug development and mitigate risks. Recognized as a top workplace and for leadership in ESG sustainability, MMS is committed to empowering its employees and driving successful outcomes for its clients on a global scale.

📋 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.

🏖️ Benefits

• supportive, innovative team • Great Place to Work certified organization • exceptional culture and industry best employee retention rate