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Director Biostatistics

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Overview

Reporting to the Executive Director and Head of BARDS Health Technology Assessment (HTA) Statistics, the Director, Biostatistics, Health Technology Assessment (HTA) will provide biostatistical and operational leadership to a team of statisticians (7-10 statisticians, including at least 3 direct reports) in developing and coordinating statistical activities in support of HTA projects, including HTA submissions. This position requires broad knowledge of clinical drug development and expertise in relevant areas of biostatistics and ideally with experience in supervising or mentoring biostatisticians.

Role Responsibilities

  • Provide biostatistical and operational leadership to sustain a high performing team supporting HTA strategies, analyses, and submissions to meet/exceed stakeholders’ expectations
  • Foster a team environment that focuses on collaboration and people development
  • Implement departmental objectives, and manage resource and operational challenges
  • Promote the development and application of innovative and value-added statistical methods
  • Interacts with multidisciplinary scientists (including health economics and outcomes research, medical affairs, clinical development and others), company affiliates project leads and Late Development Statisticians in long-range project planning and statistical guidance in support of HTA projects
  • Interacts with Academic Research Organizations, Contract Research Organizations and external statistical consultants.

Primary Activities

  • Performs managerial and administrative duties including coaching, performance management and expense report approval consistent with grant of authority
  • Directs recruiting efforts to hire qualified statisticians
  • Directs the scientific and technical development of statisticians. Encourages staff to conduct research and publish/present scientific findings and methodologies
  • Coordinates statistical project assignments and resource allocation in collaboration with other managers
  • Contributes to the definition of the HTA strategies and promotes sound and up to date statistical methodologies
  • Is involved in research activities for innovative statistical methods and applications in HTA activities
  • Provides effective and efficient statistical oversight and ensures consistency of methodological approaches for HTA projects
  • Represents HTA Statistics in meetings with management and other groups in strategic planning of projects
  • Performs comprehensive review of statistical analysis plans, statistical reports and HTA submission documents to ensure accuracy of statistical content
  • Leads the preparation of responses to queries from HTA agencies related to statistical analyses and methodologies.  Assesses the statistical rationale.

Education and Minimum Requirement

  • PhD or equivalent degree in Statistics/Biostatistics or related discipline with a minimum of 9 years relevant work experience, or Master`s with a minimum of 12 years relevant work experience.

Required Skills and Experience

  • Prior supervisory and project management experiences are necessary
  • Excellent verbal and written communication skills
  • Record of functioning effectively in a cross-disciplinary, cross-cultural team environment
  • Strong knowledge of biostatistical analysis methodologies and experimental design, including meta-analyses and time to event methodologies. 
  • Understanding of data management and clinical concepts applied to drug development within the pharmaceutical industry.
  • Working knowledge of statistical and data processing software e.g. SAS and/or R
  • Demonstrated strong interest and ability in statistical research activities and in application of novel methods to clinical development.
  • Late stage development experience

Preferred Skills and Experience

  • A record of relevant publications/presentations, professional service and familiarity with relevant emerging trends in the pharmaceutical industry is desirable
  • Good knowledge of computer systems and clinical databases systems in a statistical environment
  • Good Connections in the scientific statistical community
  • Understanding of biology of disease and drug development
  • Experience of leading role in drug regulatory/HTA environment 

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

How to Apply

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