Senior Statistical Programmer - V&I
WHY JOIN US?
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.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Do you have passion for Programming and consider yourself a subject matter expert? Would you like to apply your skills to impact drug development process and regulatory interactions in a company that follows the science and turns ideas into life-enhancing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-centric biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. Join the team dedicated to Vaccines and Immune Therapies, with an ambition of developing and delivering transformative vaccines and antibodies, providing long-lasting immunity to millions of people, where the burden of disease is greatest.
About the opportunity
You will be working in the Vaccines and Immune Therapies Biometrics Programming department providing statistical programming support and/or leading activities related to the analysis and reporting process at project/study level for the delivery of the statistical programming aspects of clinical development. The scope of work includes, but is 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 that can be pursued for development and progression.
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 Statistical programming deliverables for 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 deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
Contribute to the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
Contribute to the development of standard methodology to improve quality, efficiency and effectiveness
Measure compliance to standards and automation use
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
Strong 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 Vaccines and Immune Therapies space
Other programming languages e.g. S-PLUS, R, Python, XML etc.
Extensive knowledge of Pinnacle 21 Validator
SO, WHAT’S NEXT?
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 Canada offices will be closed from December 25th to January 1st, re-opening January 2nd. We encourage you to apply to jobs of interest and we will review applications upon our return.
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Are you interested in working at AZ, apply today!
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 emailing AZCHumanResources@astrazeneca.com.
#LI-Hybrid
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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