Principal Statistical Programming
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago



This job has expired.

Job Description

At AstraZeneca, we are committed to advancing the science of Oncology to deliver life-changing medicines to the patients most in need. Our robust Oncology pipeline includes investigational therapies in various stages of clinical development. We aspire to transform the lives of cancer patients, aiming to bring six new medicines to them by 2020.

Our Biometrics and Information Science (B&I) Group drives superior design to generate the quality data needed for key decision-making on our projects.

Our Statistical Programming department leads and delivers the programming aspects of clinicaldevelopment, managing and maintaining the end-to-end standards, Analysis and Reporting production tools and the information infrastructure. Within this group you can look forward to ground breaking work and the opportunity to make valuable contributions in a broad range of Biometrics disciplines.

Could you join us as an Associate Director of Statistical Programming in our Oncology therapeutic area?

Role

You will be leading and directing the work of a team of programmers for one or multiple drug projects and working collaboratively with B&I drug project team leaders and members. You will provide support for regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions.

In this role, you will have accountability for the quality of elements of project programming work worldwide. You will work to improve quality, efficiency and effectiveness by contributing to the development of best practice and seeking opportunities to improve the methodology, providing practical solutions for problems.

Responsibilities

Reporting to the Senior Director you will act in a strategic leadership role as part of the statistical programming function providing 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


You will 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. This will include overseeing the quality of all deliverables, holding partners and providers accountable for their outputs.

EssentialRequirements

We're seeking someone with a strong technical programming background who enjoys the challenge of leading and managing a team of programmers. You'll enjoy solving meaningful problems and formulating strategy for your team to succeed.

In addition, you will also demonstrate your:
  • Line management capability / experience - ability to drive teams to work across global & functional boundaries
  • Comprehensive knowledge of technical and regulatory requirements relating to clinical trials and submissions within the oncology therapeutic area
  • Excellent verbal and written communication skills with proven ability to influence partners
  • Ability to suggest and drive process change, contributing towards a goal of continuous process improvement


DesirableRequirements
  • BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science
  • Extensive SAS programming expertise to an advanced level
  • Knowledge of CDSIC standards and industry best practices
  • Experience leading the development and delivery of training
  • Willingness and ability to travel domestically and/or internationally
  • Extensive experience in clinical drug development or healthcare


Do you want to be part of a truly global team who pull together to put patients first? Working with some of the most respected statistical programmers, and advanced analytical experts in the industry, we will value your experience and skills and you'll see the many opportunities ahead of you.

This role could be offered at Associate Director (E) or Director (F) level depending upon the experience of the successful candidate.

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, gender or gender 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.


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