Senior Statistical Programmer / Project Lead, Statistical Programming - Gaithersburg, MD | Biospace
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Senior Statistical Programmer / Project Lead, Statistical Programming

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
12/8/2016
Position Type:
Full time
Job Code:
R-000855
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Job reference: R-000855
Posted date: Oct. 31, 2016


 

   If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.  

   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 Senior Statistical Programmer / Project Lead, Statistical Programming 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  

   This position can be either Senior Statistical Programmer - OR - Project Lead, Statistical Programming.  

   As the Senior Statistical Programmer or Project Lead, Statistical Programming, you will provide critical clinical programming support to projects.  You will interact directly and independently with Biostatisticians, Data Management, Programmers, Clinical Development staff and management as a fully functioning member of the clinical programming team.   

   Responsibilities and duties include the following:  Proactively keep the manager updated on the status, programming accomplishments and criticality of any issues impacting the quality and timely delivery of SAS Programming outputs; Work independently, with minimal supervision from the manager; Actively solicit feedback from manager to address any issues and/or complex problems; Provide accurate estimates on timelines; Lead in the development of analysis data set specifications; Independently implement and champion the use of standards and TA specific data listings, summary tables, and figures as specified in statistical analysis plan in the clinical study report; Develop robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation; Ensure compliance of standards for all SAS programming assignments; Review and provide feedback on eCRF designs, eCRF annotations, DB structures, edit checks, SAPs and SPPs; Proactively offer and provide SAS programming and analytical skills that support clinical trial and/or TA projects and programs. Provide critical clinical trial SAS programming and project management support to multiple projects. Collaborate with external partners, ensuring partners have thorough understanding of expectations via reverse knowledge transfer. Efficiently coordinate activities of other SAS programmers assigned to projects.  

Requirements

   Essential Requirements  

   For the Senior Statistical Programmerrole:  

 
       
  •      BA/BS with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.    
  •    
  •      Minimum 5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.    
  •    
  •      Has acquired advanced SAS programming skills with proficiency in Base SAS, SAS/STAT and SAS/Graph. Able to develop standard SAS macros.    
  •    
  •      Good working knowledge of CDISC guidelines. Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes.    
  •    
  •      General knowledge of medical terminology and clinical trials methodology.      
       
  •  
 

   For the Project Lead, Statistical Programmingrole:  

       
  •      BA/BS with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.    
  •    
  •      Minimum 8 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.    
  •    
  •      Superior SAS programming skills with proficiency in Base SAS SAS/STAT and SAS/Graph.    
  •    
  •      Thorough understanding of CDISC guidelines.    
  •    
  •      Broad familiarity of FDA regulations and GCP/ICH guidelines as related to clinical trial SAS programming and reporting processes.      
       
  •  
     Desirable Requirements    
       
  •      Advanced degree    
  •    
  •      Oncology experience    
  •    
  •      Excellent verbal, written, interpersonal and communication skills.      
         Sound negotiation skills.    
  •    
  •      Ability to mentor junior SAS programmers    
  •    
  •      Fully understands data interoperability across and amongst the Clinical Data Management      
         Application and all externally collected data.    
  •    
  •      Ability to effectively work within and across functional teams and therapeutic areas in a global team environment.    
  •    
  •      Good knowledge of project management, resource utilization, and negotiating skills.    
  •    
  •      Ability to proactively managing expectations on timelines for SAS programming deliverables.    
  •    
  •      Excellent organizational, analytical, and collaborative skills with the ability to manage complexity and change in a dynamic environment.    
  •  

   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  

   ~bsp  

 

   *li-medi