Do you have expertise in, and passion for, 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!
About AstraZeneca
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 Oncology, with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules in all stages of our innovative pipeline, we keep pushing forward to conquer cancer through data, innovation and evidence-based decisions.
What you’ll do
As a team member of the Oncology Biometrics Programming department, you will provide leadership of statistical programming activities related to 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.
Responsibilities
Reporting to a Director within the Oncology Programming group you will provide programming expertise in one or more of the following areas:
Lead and contribute to the 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 and contribute to the statistical programming deliverables for regulatory submissions, including specification and delivery of pooled safety/efficacy databases, outputs and response to regulatory questions, commercialisation and reimbursements
Lead/contribute to the development of standard process to improve quality, efficiency and effectiveness of the Oncology Programming group
Lead the statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER) and Investigators brochures (IB)
Education, Qualifications, Skills and Experience
Essential for the role:
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 distributed 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 partners
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 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
Experience working on Oncology clinical trials and the data generated from these.
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.
Competitive salary and benefits package on offer
Where can I find out more?
Our Social Media,
Follow AstraZeneca on LinkedIn
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Biometrics dedicated webpage https://careers.astrazeneca.com/biometrics
Date Posted
09-Mar-2023Closing Date
09-Apr-2023AstraZeneca 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 authorization and employment eligibility verification requirements.