AstraZeneca

Statistical Programming, Associate Director - Late Respiratory

Location
Cambridge, England, Cambridgeshire
Salary
Negotiable
Posted
15 Jul 2021
Closes
12 Aug 2021
Ref
R-114141
Contact
AstraZeneca UK
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Statistical Programmer, Associate Director - Late R&I

Location: Cambridge, UK, Gaithersburg, US or Gothenburg, Sweden

Competitive salary and benefits

Career level: E

Play a critical role in making our pipeline accessible to patients.

Do you have expertise in, and passion for, SAS Programming? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.

Our Late R&I Biometrics team is dedicated to the development of innovative treatment of Respiratory and Immunology (R&I) diseases. You will join a global, diverse and cross-functional environment where you will get personal and professional development.

Welcome to Cambridge (UK), one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day.

In this role, we will give you the chance to utilise your statistical programming expertise in analysis and reporting of clinical trial programs; submission and defence of regulatory filings and the generation of evidence to support product commercialisation and reimbursement.

Role

You will provide statistical programming support and/or lead programming related activities for the analysis and reporting process including, but not limited to, Clinical Study Report development, regulatory submissions, commercialisation and the scientific utilisation of our data for AstraZeneca products. There are many career options you can pursue for progression including technical pathways, management of global projects or line management.

You'll be part of a global team that pulls together to put patients first.

Responsibilities

Reporting to an Director/Senior Director, you will provide programming expertise in one or more of the following areas:

  • Lead/contribute to the delivery of the Clinical Study Report , Study Data Tabulation Model/Analysis Data Model databases and Tables, Figures and Listings through both internal and external delivery models
  • Lead/contribute to the statistical programming deliverables for regulatory submissions, including specification and delivery of overview databases, outputs and response to regulatory questions
  • Produce and maintain technical database standards and programming specification documents
  • Lead/contribute to the development of best practice to improve quality, efficiency and effectiveness
  • Development Safety Update Reports, Periodic Benefit-Risk Evaluation Report, Investigators brochures
  • Planning and executing the transfer and analysis of data for safety/efficacy monitoring boards/independent data monitoring committees

Requirements

To succeed in this role, you'll be an enthusiastic individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You'll enjoy multitasking, collaborating as part of a global team, and have an appetite for solving problems. You will be an effective communicator, with a strong team focus who enjoys collaborating to achieve the best results.

Desirable experience includes:

  • BSc in a Mathematical (i.e. Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science subject
  • Excellent problem-solving skills
  • Diligence - attention to detail and ability to manage concurrent projects and activities
  • Excellent verbal and written communication skills and ability to influence stakeholders

Statistical Programmer, Associate Director

  • Extensive SAS programming expertise to an advanced level gained within a clinical drug development or healthcare environment
  • Comprehensive knowledge of technical and regulatory requirements with submission experience
  • Wide-ranging knowledge of CDSIC standards and industry best practices
  • Travel - willingness and ability to travel domestically and/or internationally
  • Team centric approach: keen to take steps to understand and appreciate the roles, skills and strengths of others on the team

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

  • Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.

Where can I find out more?

Date advert opened: 15th July 2021

Date advert closed for applications: 15th August 2021

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