Description
Director Biostatistics : Location Cambridge, MassachusettsThe 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
1. Provides guidance and support for all biostatisticians in therapeutic areas under development; provides professional statistical support to clinical research (review protocols, analysis plans, and clinical study reports)
2. Provides input into strategy, planning and contents of clinical components of regulatory submissions; strives to increase the operational efficiency of the biostatistics group by assisting in developing policies, procedures and strategies for Biostatistics
3. Represents the company when statistical issues are part of regulatory, legal or other challenges to the company's products or processes
4. Responsible for directing overall statistical activities for the therapeutic areas assigned including implementing efficient, consistent, and practical processes for Biostatistics/Biometrics and develops, implements and monitors budgets for assigned therapeutic areas - including oversight of resource allocation and usage
5. Provides mentoring and guidance to biostatisticians towards achieving the vision and goals of Biostatistics, Biometrics and the company; develops staff through coaching and training
6. Leads inter-organizational projects or coordinates between organizations and may represent Biostatistics/Biometrics in the absence of Sr. Director, Statistics, and/or VP, Biometrics
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