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Statistical Programming, Associate Director (Principal Programmer), Late Oncology

Lieu Mississauga, Ontario, Canada Job ID R-141755 Date de publication 06/24/2022

About AstraZeneca:

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization 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. 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. Always committed to lifelong learning, growth and development.

AstraZeneca Canada

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

Would you like to be a part of a Programming group that has direct strategic impact on drug development, playing a key role in getting medicines to patients?

Our Oncology Biometrics department, of which Programming is a part of, is an integral part of the Oncology R&D organization. We drive excellent design in order to generate the appropriate data needed for quality decision making.  The goal of Oncology Biometrics is to deliver value to the pipeline by excellence in delivery, improved decision making and engaging and shaping the external environment whilst accessing and implementing innovative solutions.

Ultimately, the Oncology Programming department oversees and delivers all of the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the portfolio of drug projects within the Oncology R&D organization. 

If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.

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, commercialization and the scientific utilization 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 a Director within the Oncology Programming group 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

  • 7 years of relevant experience

  • 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

  • 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

Great People want to Work with us! Find out why:

Are you interested in working at AZ, apply today!

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship.  You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailingAZCHumanResources@astrazeneca.com.



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 authorisation and employment eligibility verification requirements.

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