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Principal Statistical Programming Oncology

AstraZeneca
Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

At AstraZeneca we are constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as together we explore synergies between small and large molecules.AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.The Principal Statistical Programmer role has heavy emphasis on delivery while also focusing on leading a clinical program utilising project management and technical leadership abilities. This role is responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members. This position requires high degree of independence, technical skills and ability to influence the team to get results without line management authority.Major Responsibilities:

  • Review a clinical study protocol with regard to statistical programming responsibilities
  • Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP)
  • Review and provide input to Case Report Forms (CRFs) and external data transfer agreements
  • Work cooperatively with and hold accountable clinical study team members including but not limited to the biostatistician, data manager, and medical writer
  • Work cooperatively with and oversee a contract programming provider
  • Assign tasks, set priorities, and provide technical help to clinical study programming teams
  • Develop and maintain SDTM and ADaM specifications
  • Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications
  • Provide accurate programming time estimates and risk mitigation plans to management or a study team
  • Proactively inform management of the status of statistical programming deliverables and issues
  • Oversee on-time delivery from clinical study programming teams and meet timelines for multiple concurrent studies
  • Contribute to or initiate standards or process improvements
    • Required Skills:
  • Excellent SAS programming skills; contribute programming to a global library of macros
  • Able to communicate clearly in oral or written form
  • Advanced knowledge of CDISC standards and applying standards to complicated data
  • Advanced knowledge of lab data processing and able to resolve issues
  • Working knowledge of medical terms, the data coding process, and coding dictionaries
  • Apply regulatory agency guidance in statistical programming responsibilities
    • Preferred Skills:
  • Able to program in other languages (e.g. R or S-PLUS, VBA, or Perl)
  • Advanced knowledge of Unix commands; able to program shell scripts for complicated tasks
  • Advanced knowledge of inferential statistics
    • Requirements/Qualifications:Education: Minimum Bachelor’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.Experience: Extensive SAS programming experience in clinical studies including leading a clinical study programming teamSupervision: Able to independently perform technical work and oversee a clinical study programming teamAstraZeneca 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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