Company Profile:

At AstraZeneca's Oncology Business Unit, we’re all here to make an impact – to achieve our bold ambition of eliminating cancer as a cause of death. We relentlessly follow the science, challenging the status quo to deliver more effective treatments to patients in need. Our dedication means we purposefully push back the limits of knowledge to change the practice of medicine. To ensure no patient is left behind, no matter what stage of disease. We’re brave disruptors – entrepreneurial, adventurous and pioneering in our approach. Here you have the opportunity to step up, take personal accountability and lead changes in our ever-evolving environment.

Job description:

JOB TITLE: STATISTICAL PROGRAMMING ASSOCIATE DIRECTOR

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

About Astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company 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. At AstraZeneca we’re dedicated to being a Great Place to Work.

About the role

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, 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.

We are offering opportunities for Statistical Programmer and Statistical Programmer Leaders at several different career levels, depending on your previous experience. You will join a global, diverse and cross-functional environment where you will get personal and professional development.

Main Duties and Responsibilities

In this role, we will give you the chance to utilize your statistical programming expertise in analysis and reporting of clinical trials and exploratory analyses to manage and generate evidence to support our product portfolio.

What You'll Do

• Lead Statistical programming deliverables for regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements

• Lead delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations

• Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)

• Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams

• Lead development of standard methodology to improve quality, efficiency and effectiveness

• Drives standards development, implementation, and measure compliance to them

• Provides inputs to capacity management while supporting recruitment and skill development by providing training and mentorship

• Employ good project management practices (estimation, risk management, status tracking) when planning and leading delivery

• Hold CRO/Partners accountable for the high-quality standards of their deliverables.

Essential Requirements

You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual.

• Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences, or similar area

• Extensive experience in clinical drug development or healthcare

• Advanced SAS Programming, CDISC standards knowledge and industry best practices

• Excellent interpersonal skills.

Desirable for the Role

• Experience working in the Respiratory or Immunology therapeutic area

• Other programming languages e.g., S-PLUS, R, Python, XML etc.

• Extensive knowledge of Pinnacle21 Validator.

WHY JOIN US?

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.