Senior Statistical Programmer - Oncology
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.
Senior Statistical Programmer is a delivery focused role responsible for programming clinical trial analysis deliverables with quality and timeliness, following established standards and processes. This position requires technical skills and adequate industry knowledge to independently perform the programming tasks while using judgement about seeking guidance in complex situations.
- 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 study team members including but not limited to the biostatistician, lead statistical programmer, data manager, and medical writer
- Work cooperatively with and oversee a contract programming provider
- Develop and maintain SDTM and ADaM specifications
- Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications
- Provide accurate programming time estimates to management or a study team
- Proactively inform management of the status of statistical programming deliverables and issues
- Meet delivery timelines for multiple concurrent studies
- Contribute to standards or process improvements
- Advanced SAS programming skills; competent with macro programming
- Able to communicate clearly in oral or written form
- Working knowledge of CDISC standards
- Working knowledge of lab data processing
- Working knowledge of medical terms, the data coding process, and coding dictionaries
- Working knowledge of regulatory agency guidance
- Able to program in other languages (e.g. R or S-PLUS, VBA, or Perl)
- Working knowledge of Unix commands; able to program shell scripts
- Advanced knowledge of inferential statistics
Education: Minimum Bachelor’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.
Experience: Some industry experience as a SAS programming in clinical studies
Supervision: Able to perform technical work independently and show good judgement about asking for guidance
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.