MedImmune Senior Principal Statistical Programmer in Gaithersburg, Maryland
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.
The Senior Principal Statistical Programmer role has heavy emphasis on delivery while also focusing on leading a clinical program utilizing project management and technical leadership abilities. This role is expected to possess superior level of technical competency and demonstrated 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.
Review a clinical study protocol with regard to statistical programming responsibilities
Review, provide input, and promote standardizationin a project or therapeutic area of Statistical Analysis Plans (SAP) and Statistical Programming Plans (SPP)
Review, provide input, and promote standardizationin a project or therapeutic area of 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
Oversee and be accountable for the performance of contract programming providers
Assign tasks, set priorities, and provide technical help to clinical study programming teams
Develop, standardize, and maintain SDTM and ADaM specifications for clinical studies in a project or therapeutic area
Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications Understand and enforce compliance with MedImmune programming standards and data standards in a project or therapeutic area
Negotiate programming timelinesand provide risk mitigation plans for clinical studies
Proactively inform management of the status of deliverables and issues
Accountable foron-time delivery from clinical study programming teams in a project or therapeutic area and meet timelines for multiple concurrent studies
Initiate standards or process improvements for a project or therapeutic area
Excellent SAS programming skills; contribute programming to and manage a global library of macros
Able to communicate clearly in oral or written form
Advanced knowledge of CDISC standards and compliance in a regulatory submission
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
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
Education: Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.
Experience: A minimum 7 years of SAS programming and leadingmultiple clinical study programming teams
Supervision:Independently performs all responsibilities, accountable for deliveries from multiple clinical study programming teams, accountable for department development
Next Steps – Apply today!
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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.