Statistical Science Director

AstraZenecaGaithersburg, MD
6d$188,000 - $282,000Onsite

About The Position

Statistical Science Director Location: Gaithersburg The Statistical Science Director has sufficient experience working as a statistician in the pharmaceutical industry to be accountable and independently lead the statistical strategy or technical activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions of a project. This individual is able to lead, perform and communicate results of more technical analyses, and able to guide less experienced staff. Competent individual contributor with excellent cross-functional collaboration.

Requirements

  • MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc
  • 7+ yrs of experience of pharmaceutical development, data analysis and interpretation and experience of program design.
  • Track record of background in leading independently
  • Experience with and broad awareness of regulatory interactions and/or submissions
  • Exemplary technical skills
  • Excellent communication skills/ builds strong relationships

Nice To Haves

  • TA or disease area knowledge expertise
  • Exposure to business development opportunities (e.g.in licencing)
  • Project management skills
  • Proficiency in programming SAS and/or R and Python

Responsibilities

  • Lead the statistical design and strategy to product development plans, clinical studies, regulatory strategy, health technology assessment and/or commercial activities as appropriate for the stage of the product
  • Lead the statistical content and ensure quality for study designs, documents, delivery and interpretation and submission
  • Quantify the benefit, risk, value and uncertainty of the emerging product profile and can communicate these effectively within the team
  • Provide global leadership to others and direct project work delivered by internal and external staff
  • Partner with CROs to ensure delivery to quality and time
  • Represent AZ externally which may include health authorities, advisory boards, conferences, workshops and/or payer interactions
  • Maintain knowledge of statistical methodology in relevant areas and promote, investigate and implement novel statistical approaches
  • Represent statistical strategy and decision making at internal decision-making governance including review boards, therapy area leadership teams and internal governance committees
  • Mentor/coach and support the technical education and training of Statistics staff

Benefits

  • qualified retirement programs
  • paid time off (i.e., vacation, holiday, and leaves)
  • health, dental, and vision coverage
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