Statistical Science Director
AstraZeneca - Wilmington, DE

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Description:
The main roles undertaken by the Statistical Science Director are Global Product Statistician (GPS), Statistical Expert or Delivery Team Leader. Statistical Science Directors provide highly experienced strategic, statistical support and leadership to product teams, specialised areas (e.g. patient safety, clinical pharmacology alliance, personalised healthcare), and the Statistics & Programming Department, in the creation of clinical development programmes to maximise the market potential of AstraZeneca products

Statistical Science Directors provide statistical consultancy and set statistical standards within the Global Statistics and Programming Group. They have an external focus and a positive image through attending meetings, and producing publications.

Major Responsibilities

GPS

  • The GPS is accountable for providing strategic, scientific expertise to quantify the benefit, risk, value and uncertainty of the emerging product profile throughout the lifecycle of the drug development process.
  • The GPS is accountable for leading the statistical thinking and contributions to the creation and development of target claims, benefit/risk/value assessment, Brand Business Plan, Clinical Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Exploitation of AZ products.
  • Expert statistical leadership to the Design and Interpretation Working Group (core member) and to the Global Product Team.
  • Ensure efficient and effective leadership and management of project information, strategy, quality standards, and integrity of information interpretation.
  • Accountable for the statistical work on the product worldwide and for leadership to the internal and external statistical staff world-wide assigned to the compound/product
  • Represents AZ and Statistics to Health Authorities worldwide;
  • Provide support the wider scientific development of the product;
  • Network with colleagues and experts, providing statistical consultancy in own area of expertise and serving as a resource for others by sharing experience within and beyond project team and Statistics function.
  • Identify options and opportunities for innovative thinking and approaches to improve quality, cost or time and where appropriate lead the development of new methodology or process to provide business benefit
  • Negotiation of time frames for statistical project activities.
Statistical Expert

  • To provide expert statistical review and consultancy across all the drug projects within their area of expertise to ensure that clinical development programs (or parts assigned) meet scientific, regulatory, quality, cost, and commercialization requirements as pertain to their area of expertise.
  • To provide statistical expertise to help establish standards and best practices to optimize the regulatory success and commercial value of AZ products, which will enhance the value and contribution of Statistics and Programming.
  • To promote, investigate, develop and implement novel statistical approaches in the expert area, for relevant statistical issues and/or regulatory guidance and/or value demonstration. To maintain broad awareness of statistical issues and the evolving regulatory environment relating to development of products within area. To examine external regulatory and scientific environment and identify any key areas, issues, trends, or emerging initiatives where direct involvement of AZ Statistics and Programming would be beneficial and to provide or organize that direct involvement.
  • To develop relationships with international opinion leaders and collaborative groups to enhance the value and contribution to function and statisticians in the external scientific/academic community.
  • To provide consultation to relevant leadership teams and clinical team members on statistical issues, risk management, issue management and strategic direction.
  • To provide expert consultation/perform statistical assessment/presentation of in-licensing/out-licensing proposals within the area of expertise
  • Interact with Health Authorities and external consultants as appropriate
  • To support the education and training of Statistics staff in relevant new statistical methodology through
GPS

  • Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, from different phases of development
  • Experience of effective use of modelling and simulation to improve clinical program design and decision making
  • Experience of quantification of benefit, risk, value and uncertainty
  • Experience of major regulatory interactions and/or regulatory submissions
Statistical Expert

  • Extensive expert area knowledge
  • Extensive experience in area of expertise in the context of drug development
  • Experience of effective use of modelling and simulation to improve clinical programme design and decision making
  • Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, from different phases of development
  • Experience of quantification of benefit, risk, value and uncertainty
  • Well respected and highly credible within the statistical arena
Skills and Competencies

  • Leadership
  • Passion for Customers
  • Thinking Strategically
  • Acts Decisively
  • Drives Performance
  • Works Collaboratively
  • Develops People and Organisation
  • Broad statistical knowledge (technical skills)
  • Communication skills
  • Strategic thinking and influencing
  • Innovativeness
  • Judgement/integrity
  • Proven Project Management skills
  • Negotiation Skills
  • Cross Cultural Awareness
Internal and External Contacts/Customers

Internal -- Design and Interpretation Working Groups, Clinical Project Teams, Global Product Teams, Therapy Area Clinical Vice-Presidents, Chief Medical Officer, Chief Statistical Expert, Regulatory Affairs, Global Marketing

External -- expert groups, Regulatory Authorities, professional/industry societies, expert advisors, and external partners

Reporting Relationship

No direct reports; reports to Group Manager, Statistics

Minimum Requirements

  • Essential --MS in Statistics or Medical Statistics with at least 10 years experience as a statistician in the health care environment or relevant areas of statistical applications.
  • Desirable --PhD in Statistics with experience as a statistician in the health care environment

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AstraZeneca Pharmaceuticals (which does business as AstraZeneca US) can help with a full alphabet of ailments. The company, a subsidiary of...