Associate Director/Director Statistical Programming, Oncology - Gaithersburg, MD | Biospace
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Associate Director/Director Statistical Programming, Oncology

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
12/7/2016
Position Type:
Full time
Job Code:
R-000858
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Cambridge, United Kingdom
Job reference: R-000858
Posted date: Dec. 05, 2016


 

   At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As an Associate Director, Statistical Programming(Grade E)/Director, Statistical Programming(Grade F) - Oncology  you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.  

   AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.  

   Main Duties and Responsibilities  

   We are currently seeking an Associate Director/Director, Statistical Programming to work within our Oncology Therapeutic Area Programming team.  

   Join AstraZeneca as an Associate Director/Director, Statistical Programming, Oncology in Biometrics & Information Sciences (B&I) and you will play a key role in delivering our exciting drug development portfolio within the Global Medicines Development (GMD) organisation.  GMD progresses products through late-stage development, registration, and ongoing post-launch development activities – providing a consistent, global platform dedicated to conducting trials for both small molecules and biologics.  

   Within Biometrics & Information Sciences, the Associate Director/Director Statistical Programming provides strategic, global programming leadership for one or more projects or a therapeutic area (TA) franchise.  The Director Statistical Programming plays a key role in planning the TA submission strategies, ensuring delivery of studies and submissions, and integrating data from AstraZeneca’s external partnerships and acquisitions.  With our outstanding drug portfolio and numerous submission targets, it is an exciting time to join AstraZeneca!  

 
       
  •      Biometrics & Information Sciences drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.    
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  •      Programming is the department that oversees and delivers the programming aspects of clinical development, manages and maintains the end to end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.    
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  •      TA Programming is the group that oversees and delivers all the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the TA portfolio of projects.     
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   As Associate Director, Statistical Programming you will ensure quality and delivery of B&I Programming contributions to drug projects across all AstraZeneca delivery models (in-house, outsourced, collaborations, etc.). You will lead and develop a group of programmers within one or more projects and provide strategic input and leadership to the delivery of all technical programming and information components of a project as the lead Global Product Programmer role.  Additionally, you will be the lead of the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners.  As the Associate Director you will lead programming support to the regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions. You will be identifying opportunities to improve the methodology and provide practical solutions for problems as well as contributing the development of best practice to improve quality, efficiency and effectiveness. You will be involved in leadership and management of programming staff on the product world-wide so that all work is carried out with regards to AstraZeneca standards and external regulations.  

   For the Director position, you will do all of the Associate Director tasks as well as lead and develop a group of programmers within a therapeutic area franchise. You will provide expert information management and leadership skills to influence and promote consistent approaches to data integration activities. As the Director you will contribute to and champion best practices to enhance the value and contribution of Programming across other therapeutic areas. Finally, you will provide a coordinated and consistent approach to the specification and presentation of analysis ready information and integration of data, utilizing appropriate standards and practices.  

Requirements

   Essential Requirements  

       
  •      BSc in Mathematical, Statistical, Computer Science or Life Science.    
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  •      Extensive SAS programming expertise to an advanced level.    
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  •      Comprehensive knowledge of technical and regulatory requirements related to the role.    
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  •      Proven programming leadership experience and role-relevant scientific knowledge within a TA    
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  •      Knowledge of CDASH/SDTM/ADaM CDISC standards.    
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  •      Extensive experience of global regulatory submissions.    
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  •      Excellent written and verbal communication skills and practices.    
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   ~bsp  

   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.