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Principal Statistician – Centralized Monitoring

Location Warsaw, Mazovia, Poland Job ID R-076250 Date posted 05/14/2020

The Principal Statistician, Centralized Monitoring is responsible for the implementation of centralized monitoring services in large, multi-site clinical studies. The individual needs to have a solid background in statistics and data analysis in clinical development, strong project management and leadership skills, and an understanding of using statistical techniques for investigating data integrity.

The Principal Statistician – Centralized Monitoring is a member of a team providing centralized monitoring (CM) service in large, multi-site clinical trials. This role is particularly, although not exclusively, focused on Central Statistical Monitoring (CSM). CSM involves univariate and multivariate statistical analysis of variables to compare within and across sites. The objective of CSM analysis is to identify non-random errors or patterns that may be the result of data integrity issues such as GCP misconduct, including fraud, e.g.:

•        Fabricated or omitted data

•        Lack of precision or mis-calibrated equipment

•        Incorrect randomizations (e.g. failure of inclusion/exclusion criteria)

•        Patients enrolling at multiple sites (professional subjects)

The Principal Statistician CSM will:

  • Execute the implementation of CSM services that is aligned with Development Operations and Quality Training and Risk Management organization vision
  • Cooperate with CM Leadership Team and other roles in CM team for development and maintenance of CSM processes, standards and framework
  • In consultation with clinical study teams, help develop the CSM strategy and plans for individual clinical studies and development programmes. 
  • Undertake the full range of duties relevant to the leadership and project management
  • Carry out CSM at defined points in the trials and report on findings to the study statistician and study team.
  • Perform further investigations on potential data integrity issues.  
  • Produce CSM analysis plans and CSM reports & appendices for each defined timepoint.
  • Provide quality control and validation support for CSM plans, analyses and reports, as appropriate.  
  • Drive the development and implementation of new statistical methods for CSM, CM and RbQM, collaborating with study teams to understand the importance of different variables, critical-to-quality factors and key risk indicators.
  • Interact with external vendors providing CSM tools and advice on the CSM implementation strategy.
  • Adhere to corporate policies, corporate vision, training and development.
  • Demonstrate AZ values, including taking an active role in departmental, functional, or locational activities.
  • Maintain a positive, result oriented work environment, building partnerships and modelling team work, communicating to the CMLT and other teams in an open, balanced, and objective manner.

Requirements:

Essential:

  • MSc or PhD biostatistics, mathematics, informatics, computer science, the physical sciences or related subject
  • Strong experience of clinical drug development statistics & the pharmaceutical environment
  • Demonstrated current understanding of GCP and regulatory requirements as they relate to Risk Based Monitoring, Risk Based Quality Management and Centralized Statistical Monitoring
  • Understanding of CSM and RbQM, and their impact on study conduct & integrity, interpretation of extreme / outlying and missing data
  • Experience of programming and data handling using SAS software
  • Knowledge of CDISC SDTM and ADaM standards
  • Understanding and role model for the AZ values and behaviours
  • Demonstrated project management skills for own workload
  • Ability to work independently
  • Demonstrated ability to work and interact effectively with external partners, including senior functional management
  • Strong written and verbal communication skills
  • Ability to work in a global team environment
  • High attention to detail and accuracy
  • Excellent collaboration – needs the energy, tact and influence to work successfully across global & functional boundaries
  • Strong understanding and role model for the AZ values and behaviours
  • Demonstrated project management and leadership skills
  • Strong communication and interpersonal skills
  • Strong organizational and analytical skills
  • Strong problem and conflict solving skills
  • Ability to work in a global team environment
  • Demonstrated effectiveness in managing change
  • High attention to detail and accuracy

Desirable:

  • Experience of advanced innovative statistical techniques for CSM
  • Experience of programming and data handling using R
  • Experience of JMP/Clinical software
  • Experience of main therapeutic areas: Oncology, ImmunoOncology, Respiratory, Inflammation & autoimmunity, Cardiovascular, Renal & Metabolic diseases
  • Excellent collaboration – needs the energy, tact and influence to work successfully across global & functional boundaries
  • Analytical thinking
  • Travel – willingness to travel domestically & internationally
  • Diligence – attention to detail and ability to project manage multiple concurrent activities



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.