Sr. Clinical Programmer - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
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Sr. Clinical Programmer - (Gaithersburg, MD)

MedImmune, LLC

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Gaithersburg, Maryland, United States
Job reference: R-006573

Posted date: Apr. 27, 2017



   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.  As a Sr. Clinical Programmer in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

   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.  

   Main Duties and Responsibilities  

   As the Sr. Clinical Programmer, you will work with data management and clinical study teams in the activities related to programming edit check listings and validating output of data review listings for ongoing clinical studies.  Design, develop, implement and validate complex SAS programs to process, analyze and report clinical trial data for review by clinical teams.  Interact with various teams including Data Management, Clinical Operations, Statistical programmers, and Clinical & Regulatory staff associates supporting Clinical trials.  Deliver output from programming requests effectively for department members as needed on a timely basis. You will oversee programming documentation and ensures consistent maintenance of code, logs and output within a regulated computing environment.  Create and manage data transfer specifications for external data following CDSIC standards.  Plans and establishes programs for processing data transfers and performs programmatic quality checks.  Perform SAS programming to provide complex data review listings and reports to support Data Management, Medical Coding, and other areas of Clinical Biologics functions for Oncology trials. Develop reports & graphs in JReview for easier data review and visualization. This includes developing programs for patient profiles on an ad hoc basis to support the clinical trial teams for Oncology trials.  Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities to support Data Management and other areas of Clinical Biologics for data review.  You will develop and maintain programs, tools and documentation for testing and organizing SAS datasets.  Ensure all programming activities and processes performed are conducted per standard operating procedures, guidelines and best practices.  


   Essential Requirements  

  •      Bachelor’s degree or equivalent in computer science or statistics and knowledge of SDTM programming, knowledge of EDC systems.    
  •      Minimum 5 years’ experience in a SAS programming environment within the pharmaceutical industry.    
  •      Experience in working with data visualization and reporting tools, preferably JReview.    

   Desirable Requirements  

  •      Strong knowledge of SAS programming in Windows and UNIX environments.    
  •      Proficiency in Programming in JReview, JReview Dashboard, SAS/Base, SAS Macros, SAS Graph.    
  •      Extensive experience handling external data, such as lab data, PK, and imaging data.    
  •      Experience developing reports using JReview.    
  •      Good understanding of standards specific to clinical trials such as CDISC, SDTM, MedDRA, WHODRUG.    
  •      Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, Rave, and underlying data structure is a plus.    
  •      Knowledge of data management process, good understanding of data cleaning process.    
  •      Strong problem solving skills.    
  •      Able to work independently and as a team player, good organizational and time management skills.    
  •      Capable of communicating technical concepts at various levels.    
  •      Good understanding of system development life cycles, GCP, and related regulatory guidelines.    
  •      Good Problem solving skills, attention to detail, good verbal and written communication skills. SAS systems experience includes Base SAS, SAS/Stat, Macro Facility, SAS/Graph. Experience with CDISC models, SDTM and ADAM.    

   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.