Statistical Science Associate Director

AstraZenecaGaithersburg, MD
3d

About The Position

The Statistical Science Associate Director has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complex project or complex studies. This individual is able to lead and direct Biometrics work either in house or partnering with CROs to ensure delivery to quality and time. Typical Accountabilities: The Statistical Science Associate Director may work as a lead statistician • For a project or indication in clinical therapeutic areas • Leading the delivery and oversight on a multiple studies/indication within a project, potentially as a Global Project Statistician for a standard drug project The accountabilities for supporting projects directly include: • Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment and/or commercial activities • Direct project work, including statistical staff and/or CRO partners, to ensure delivery to standards, quality and time • Develop design options and provide high quality decision support to enable the business to make informed decisions about a study or project • Quantify the benefit, risk, value and uncertainty of the emerging asset/product profile • Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation • Mentor/coach and support the education and training of statistics staff

Requirements

  • MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc
  • 5+ yrs of experience of pharmaceutical development, data analysis and interpretation and experience of program design.
  • Strong knowledge of programming in R and/or SAS
  • Knowledge of the technical and regulatory requirements related to the role
  • Excellent communication skills and ability to build strong relationships
  • Excellent collaboration skills to work across functional boundaries
  • Ability to apply statistical expertise to complex problems, with a focus on problem solving and quality.

Nice To Haves

  • Project Management Skills
  • Proficiency in SAS and R/Python languages

Responsibilities

  • Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment and/or commercial activities
  • Direct project work, including statistical staff and/or CRO partners, to ensure delivery to standards, quality and time
  • Develop design options and provide high quality decision support to enable the business to make informed decisions about a study or project
  • Quantify the benefit, risk, value and uncertainty of the emerging asset/product profile
  • Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation
  • Mentor/coach and support the 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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