Senior Statistical Programmer job in Gaithersburg
|Employer:|| AstraZeneca Pharmaceuticals|
|Category:||Research and Development|
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. |
We're 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 part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune 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
•Understand and comply with MedImmune programming standards and data standards
•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 : Advanced d egree (MS/PhD) with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. PhD Preferred.
Experience : A minimum 3 years of SAS programming in clinical studies
Supervision : Able to perform technical work independently and show good judgement about asking for guidance
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual 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 . AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised
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