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Principal Statistician, Oncology

Plats Gaithersburg, Maryland, USA Jobb-id R-064523 Datum inlagd 10/28/2019

Principal Statistician, Oncology

Those who join AstraZeneca feel a sense of ownership about their future. They thrive with a recognized leader in the industry.  AstraZeneca is an agile, fast-moving and emerging industry leader in oncology. We are a nimble organization that values smart risk-takers. With AstraZeneca, you will be applying a creative approach to science while being at the forefront of a strong and rich pipeline of cutting-edge medicines.      Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities. 

Our Oncology Pipeline

Our robust pipeline includes investigational therapies in varied stages of clinical development, from recently approved products to earlier-stage molecules in clinical trials. We aspire to transform the lives of cancer patients, working to eliminate cancer as a cause of death in the future.

We have an exciting opportunity for Principal Statistician located in our Gaithersburg Maryland Office.

Position Summary


In this role you will provide statistical expertise for complex design and interpretation of clinical studies, regulatory submissions and commercialization. You will also:

  • Analyze internal and external information to inform design decisions and the development of decision criteria 
  • Develop a Statistical Analysis plan for complex studies and/or project deliveries 
  • Provide support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions 
  • Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions 
  • Identify opportunities for the application of modelling and simulation to improve study design 
  • Identify and apply statistical methodology to improve the process and delivery activities 
  • Perform ad hoc and exploratory data analyses
  • Contribute to the development of best practice to improve quality, efficiency and effectiveness  

Summary and Qualifications for Principal Statistician

Principal Statisticians provide highly experienced strategic input and statistical expertise, to project teams in the design and interpretation of clinical studies and clinical development programs .  Provide statistical leadership either in support of the Global Product Statistician (GPS), be a newly appointed GPS, or lead strategic capability or business area improvements with minimal supervision.  May serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), and integrated product development plans (iPDP).  Perform statistical analyses and create statistical text for clinical publications and other communications. Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables

Qualifications:

  • MSc or PhD in Statistics, Biostatistics, or Mathematics (containing a substantial statistical component). Ph.D. preferred.
  • Preferred 4+ years experience.working within a statistical role for Principal Level and preferably in pharma/healthcare or other relevant area 
  • Knowledge of the technical and regulatory requirements related to the role and able to guide others on these 
  • Experience in drug development, study design, and data analysis and interpretation  
  • Excellent communication skills and ability to build strong relationships
  • Excellent collaboration skills required – the energy to work across global & functional boundaries, both internally and externally
  • Project management skills 
  • Ability to apply statistical expertise to complex problems, problem solving and quality focus
  • Expert statistical programming skills (SAS and R) 
  • Experience in Oncology product development preferred
  • Experience in commercial or early development support work preferred 


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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