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16 Jul 2019

Full-Time Associate Director, Statistical Innovation

egeurtse – Posted by egeurtse Anywhere

Job Description

Job Description

The Associate Director is responsible for collaborating with clinicians and supporting the Senior Director, Statistical Innovation in evaluating, developing and deploying advanced and novel statistical/analytical methodology and associated tools in Clinical Development. This position will research strategic methodological and operational solutions to Mallinckrodt’s (MNK) most challenging clinical development problems. A strong individual contributor and a dynamic cross-functional team leader, the Associate Director of Statistical Innovation collaborates with clinical, regulatory, statistics, programming, data management, to broadly impact the drug development strategy by creating new ways to advance medicines to patients.

Principal Responsibilities
· Enhance understanding of clinical development landscape via deep diving in data and integrate knowledge with published research.
· Contribute to critical decision making in clinical development strategies such as study design, endpoints and dose selection with modeling and simulation methodologies
· Develop and execute modeling and simulation plans and analyses fully integrated with the overall clinical development plans.
· Proactively trouble-shoots weaknesses in data totality based on statistical principles
· Serve as full partner to clinical development team and subject area expert in challenges like Adaptive Designs, data mining applications, advanced analytics and complex innovative designs.
· Educate MNK clinicians on emerging or existing advanced statistical methodology. Explain complex methodological concepts to project team members. Drive change through influence, negotiation and collaboration
· Performs statistical analysis, interprets statistical results and oversees any outsourcing of such tasks
· Create tools (e.g., R-shiny, SAS, R etc.) and platforms that operationalize key methodology making diverse approaches available to study teams

Department specific/Non-essential responsibilities:

Other duties as assigned with or without accommodation.

Minimum Requirements

Education Required:

· PhD in statistics or related field

Experience / Skills:

· 5+ 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


· Working knowledge of advanced statistical methods (e.g. Adaptive designs, Bayesian methods, multiplicity, subgroup identification/data mining, predictive modeling etc.).
· Experience in Modeling and Simulation in support of drug development programs
· Hands-on skills in R, SAS and similar tools
· Excellent verbal and written communication skills
· Ability to communicate with clarity and influence to drive change and innovation.

Organizational Relationship/Scope:

This position will work with multiple functions outside of Clinical Development. Key Stakeholders

· Clinical Development TA Heads

· Regulatory Affairs TA leadership

How to Apply

If interested and qualified, please visit the link below to apply:

Job Categories: Equal Opportunities. Job Types: Full-Time.

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