At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 a Associate Director, Durham, NC, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Position description

•   Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making.  B&I’s goal 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.
•   Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure. 
• TA Programming is the business unit that oversees and delivers all the statistical programming contributions to internal decision making, regulatory submissions, and reporting and commercial activities for a therapy area (TA) portfolio of projects.
• Standards & Business Solutions (SBS) is the business unit that develops and maintains end-to-end clinical data standards, leads and contributes to B&I’s process and infrastructure initiatives, and provides cross-TA Biometrics deliverables, resources, and support to late-stage drug project teams. 

Typical Accountabilities

• Act as the strategic computer programming leader to provide support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialization and scientific utilization data for AZ products.   
• Lead 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. 
• Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable.
• Lead programming support to the regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions.
• Identify opportunities to improve the methodology and provide practical solutions for problems.
• Contribute to the development of best practice to improve quality, efficiency and effectiveness

Job Dimensions

• Leadership role, able to lead and direct project work
• Accountable for the quality of elements of project programming work worldwide
• Accountable for good Information Practice on all assigned activities.

Education, Qualifications, Skills and Experience

Essential             

• BS in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science, Life Science or related field
• Extensive SAS programming expertise to an advanced level
• Comprehensive knowledge of technical and regulatory requirements related to the role
• Knowledge of CDISC standards and industry best practices
• Extensive experience in clinical drug development or healthcare
• Experience in Regulatory submissions
• Excellent verbal and written communication skills and influence stakeholders
• Lead the development and delivery of training   

Desirable

• Advanced to expert verbal and written communication and collaboration skills.
• Advanced to expert problem solving and conflict resolution.
• Drive others to work across global & functional boundaries.
• Travel – willingness and ability to travel domestically and/or internationally.
• Ability to apply programming knowledge and skills to problems, problem solving, and quality focus.  Troubleshoots for team.
• Contributes to defining business processes and accurately completes and manages associated documentation.
• Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
• Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.

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. 

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.