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Title:Associate Director, Biostatistics
Salary:$120K-145K+
Experience:5+
Location:MA - Cambridge

Description:
The Associate Director will manage the Biostatistics activities for one or more clinical development programs groups within Biometrics. Possesses an advanced understanding of modern drug discovery and development processes. Oversees the entire design, development and evaluation process for the technical/statistical infrastructure for the conduct and evaluation of all clinical trials, from inception to completion. The Associate Director is responsible for the implementation of assigned projects and services, with optimal efficiency, through effective leadership, as well as the work performance and technical development of their staff. The Associate Director is responsible for providing expert technical guidance to Biostatisticians and other staff on project teams. The Associate Director will foster interdisciplinary understanding within the groups and integrate activities with those of other groups, Departments and project teams, wherever possible. 

Responsibilities:
  • Leads and manages the technical operations of assigned projects and provides technical guidance and mentoring to project team(s).  Has demonstrated outstanding diligence and competence in a managerial role.  Demonstrates advanced and inspiring intellectual and technical leadership.
  • Leads team(s) in the areas of experimental design, protocol development, statistical analysis plans and statistical analysis to meet project objectives, and development statistical section of clinical study reports, INDs, NDAs, and annual reports.
  • Has proven ability of excellent cross-functional project management skills, including an impressive track record of consistently meeting all project timelines and objectives.
  • Acts as liaison on behalf of department with internal personnel and outside customer representatives at various levels concerning processes or scheduling of specific phases of projects or contracts.
  • Communicates company objectives to the group(s) in a clear and timely manner.
    May construct estimates of project resource requirements and time lines and routinely provides management with status updates.
  • Keeps abreast of relevant literature and is able to make highly intelligent recommendations regarding new technologies and methodologies to group.
  • Demonstrates innovation and creativity in aligning technology with and driving line of business objectives.  Seeks out and plans technical direction for the group(s) and promotes technological innovation. 
  • Makes technical presentations, both internally and externally, and is recognized as an authority on a wide range of topics relevant to their area of technical expertise.
  • Works independently, applying judgment in determining the best methods and techniques to achieve results requiring evaluation of intangible factors.
  • Ensures compliance with, and participates in development of SOP's and ICH GCP regulations and helps craft department goals and ensures linkage to personnel goals in support of the corporate and department goals.
  • Develops draft budgets and manages approved budget for group(s).  Proven ability to plan and manage capital and operating budgets, as well as plan and advocate staffing resources. Makes hiring decisions and may be required to supervise other Biometrics staff, with all incumbent supervisory responsibilities. 

Requirements:
  • Ph.D. (or equivalent degree) and minimum of 10 years of relevant experience, or
  • M.S. (or equivalent degree) and minimum 12 years of relevant experience.

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