Director, Statistical Innovation

Proclinical is currently is seeking a Director of Statistical Innovation for a pharmaceutical company located in Bedminster, NJ. Successful candidate will be responsible for providing statistical leadership in evaluating, developing and deploying advanced and novel statistical/analytical methodology and associated tools in Clinical Development.

Job Responsibilities:

• Deploy modelling and simulation capabilities and activities in support of drug development scenario planning and program optimization.
• Provide consulting for statisticians and clinical teams.
• Collaborate with different S&T Department/Divisions to optimize clinical trial study designs and programs.
• Operate as a full partner to clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory, operation functions to drive quantitative decision making in drug development and enable successful impact on development programs and trials.
• Serve as a leading representative engaging on external industry challenges like Adaptive Designs, data mining applications, advanced analytics and complex innovative designs.
• Educate the statisticians and clinicians on emerging or existing advanced statistical methodology.
• Create tools and platforms that operationalize key methodology making diverse approaches available to study teams.

Skills and Requirements:

• PhD in statistics or related field.
• 8+ years of experience in the pharmaceutical or biotechnology field.
• Strong oral and written communication skills.
• Demonstrated project and technical leadership qualities, and creative and strategic thinking required.
• Knowledge of FDA/CHMP guidelines, GCP, Clinical research, Fundamentals of Project Management, working in a matrix-based environment is a must.
• Must be comfortable with hands on analysis of data using novel statistical techniques.
• Demonstrated expertise in advanced statistical methods.
• Functional knowledge of machine learning/AI and Big Data.
• Experience in Modeling and Simulation in support of drug development programs.
• Ability to communicate with clarity and influence to drive change and innovation.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Natasha Patel at (+1) 617-778-7319 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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