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Senior / Principal Statistician – Centralised Statistical Monitoring (CSM)

Astrazeneca

At AstraZeneca we are excited by the possibilities and opportunities that our work offers us in having an impact on the lives of patients. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.

The Advanced Analytics Centre (AAC) uses a blend of scientific and technical skills (statistics, informatics, computer science, mathematics and tool development) to develop and deliver cutting-edge methods which address critical scientific and business questions in drug development.

Quantitative Solutions (QS) is a centre of excellence within the AAC for high quality delivery of advanced analytics services, tasks and tools. It is a fast paced, collaborative environment where we make a strategic impact.

We are seeking experienced statisticians at both Senior and Principal level to join our team of likeminded colleagues, to further develop AstraZeneca’s centralised statistical monitoring capabilities.

Role

Centralised Statistical Monitoring (CSM) is becoming an integral part of Risk Based Quality Management (RbQM) for clinical trials and contributes toward the success of our regulatory submissions, by identifying and managing issues affecting data integrity.

In this pioneering role at AstraZeneca you will be a part of a newly formed team providing CSM for large, multi-site clinical trials. You will champion the use of CSM within the organisation and will also remain very ‘hands-on’, with involvement at every stage in the CSM process, from devising the CSM analysis plan, to running the CSM statistical analyses and writing the CSM report.

This role reports to the Head of Quantitative Solutions. 

Main Duties and Responsibilities

In consultation with our clinical study teams, you will help develop our CSM strategy and plans for individual clinical trials and development programmes.  You will produce CSM analysis plans and CSM reports & appendices across the portfolio of clinical trials.

In this truly ‘hands-on’ role you will carry out CSM at defined points in the trials and report on findings to the study teams, running sophisticated statistical analyses to detect and investigate potential data integrity issues through:

  • Identification and understanding of the implications of missing data
  • Identification of:
    • univariate and multivariate outliers and their impact on data integrity
    • unusual patterns in data
    • duplicate subjects
  • Using graphical techniques for data appraisal

     

    Responsibilities will also include:

  • Assisting in the development and implementation of new statistical methods for CSM and RbQM, collaborating with study teams to understand the importance of different variables, critical-to-quality factors and key risk indicators
  • Interacting with external vendors providing CSM tools and advice on the CSM implementation strategy
  • Working closely with the AZ Centralised Monitoring group, including provision of training and guidance as required
  • Engaging with stakeholders to determine project requirements
  • Reviewing working practices and ensuring non-compliant processes are escalated

     

    Requirements

    ESSENTIAL   

    To be successful in this role you will need to have:

  • Strong experience of statistical analyses and programming in SAS within a clinical drug development setting
  • MSc or PhD biostatistics, mathematics, informatics, computer science, the physical sciences or related subject
  • Understanding of and interest in CSM and RbQM, their impact on study conduct & data integrity, and interpretation of extreme / outlying and missing data
  • Very strong attention to detail and appetite to solve technical problems
  • Good knowledge of CDISC SDTM and ADaM standards

     

    DESIRABLE

    In addition, experience in any of the following would be advantageous:

  • Advanced innovative statistical techniques for CSM
  • JMP/Clinical software
  • Main therapeutic areas: Oncology, ImmunoOncology, Respiratory, Inflammation & autoimmunity, Cardiovascular diseases, Diabetes & Metabolic diseases
  • Project management skills

 

This is a permanent, full time role, based in Central Cambridge, UK.

Salary - Competitive salary and company benefits apply.

To be considered for this exciting opportunity, please apply today.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Closing date for applications – 30th April 2019