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

Company: AstraZeneca
Location: Berkeley
Posted on: August 5, 2022

Job Description:

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? At AstraZeneca every one of our employees makes a difference to patient lives every day. We are building on our strong pipeline and turning ideas into life-changing medicines that benefit patients around the globe. 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 This role can sit at our Gaithersburg, MD; Wilmington DE; South San Francisco, CA; or Waltham, MA location AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation. 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 authorization and employment eligibility verification requirements. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Keywords: AstraZeneca, Berkeley , Statistical Programming, Associate Director (Principal Programmer), Late Oncology, IT / Software / Systems , Berkeley, California

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