Director Biostats

Company Overview
Global CRO

Job Description
 Works cooperatively with Statistical Programming and Biostatistics leadership to establish and maintain Standard Operating Procedures (SOPs) and guidelines, promoting standardized and consistent processes to maximize the efficiency of the department.
 Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget.
 Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching.
 Responsible for staff development of entire reporting hierarchy, training and retention. Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies meeting the business needs of the department.  Makes recommendations for, and participates actively in hiring, onboarding, transferring and terminating staff.
 Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates.  Meets with subordinate managers routinely to evaluate and develop solutions for project resourcing, quality, timelines, budget, standard processes, and training needs. Keeps senior management informed of decisions and issues which impact the department.
 Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges.  Directs and coordinates biostatistics activities, and supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience.
 Conducts senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents.
 May be responsible for leading or participating in projects across multiple studies or programs.
 Leads departmental or corporate initiatives.  Supports business development activities.
 Performs other work-related duties as assigned.  Minimal travel may be required

Requirements
Graduate degree or equivalent, in Statistics or related field.
 Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility.
 Progressive management experience and demonstrated leadership ability.
 Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines.
 Experience with regulatory submissions preferred.
 Ability to apply knowledge of statistical design, analysis, and programming techniques used in clinical trials.
 Ability to read, write, speak, and understand English.  Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade.

日本東京 地図

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