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Principal Biostatistician

1 month ago

London, United Kingdom SRG Full time

Principal Statistician


Short role description

The Statistician has in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complex project or be recognised as a methodology expert. 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 Principal Statistician may work as a lead statistician:

  • For a project or indication in clinical or preclinical 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
  • Contributing to statistical methodological advances


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


The accountabilities for supporting statistical methodological advances include:

  • Ability to consult across project teams within area of expertise
  • Application of expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation
  • Produce pragmatic solutions, often within a tight time scale where the emphasis will be to deliver first, then refine and develop solutions thereafter
  • Contribute to/or lead the development of a process improvement and/or capability area within the department
  • Establish and improve standards and best practice, apply novel statistical approaches to increase effectiveness and efficiency
  • Interact with external scientists and represent AstraZeneca Biometrics externally via publications and presentations on novel statistical approaches and best practice
  • Mentor/coach and support the education and training of statistics staff in the technical arena


Education, Qualifications, Skills and Experience

Essential:

  • MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc
  • 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


Technical:

  • Usually PhD in statistics or a relevant topic
  • Experience of independent research
  • Delivering innovative statistical solutions in an applied environment


Desirable:

  • Project Management Skills
  • Proficiency in SAS and R/Python languages
  • Knowledge of Bayesian statistics from theory to computation is a plus


Technical:

Track record of research and methodological development in Statistics, supported by scientific publications in first class statistical journals


Key stakeholders and relationships

• All levels of functions within Biometrics

• Therapeutic area scientists

• Collaboration partners in other departments

• Drug project functional leads

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