Director Biostatistics Biogen Cambridge

Job Description The Director of Biostatistics is responsible for providing direct supervision for one or more therapeutic area leader(s). He/She also provides direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects.



He/She provides mentorship to biostatisticians in the department. He/She is responsible for implementing consistent statistical conduct for the department in all locations. He/She also provides guidance to the department towards achieving departmental and corporate visions and goals.

• The Director maintains liaison with clinical research personnel in order to identify and meet their needs for statistical support. He/She interacts with head of statistical programming and data management to synchronize prioritization of projects and in some cases, he/she represents Biostatistics in meetings with executive committee, commercial, regulatory agencies, and external development partners in the absence of the Senior Director of Biostatistics
Location Cambridge, MA, US

Qualifications

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• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
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• Ability to develop innovative/creative statistical/technical solutions to complex problems
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• Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
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• Broad knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas
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• Attentive to detail
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• Able to write and present information effectively
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• Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
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• Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
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• Able to manage staff
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• Demonstrates excellent leadership and communication skills
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• Demonstrates strong organizational skills, including the ability to prioritize.
• Past frequent interaction with FDA
• BLA/NDA experience essential
• Interaction with EMEA/CPMP and preparation of an MAA an advantage.
Education PhD with at least 10 years working on clinical trials

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