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Job Details

Associate Director Statistical Programming Early Oncology

Company name

Gaithersburg, MD, United States

Employment Type

Manager, Healthcare, It

Posted on
Jan 22,2020

Valid Through
May 06,2020

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At AstraZeneca our Oncology Biometrics department is an integral part of the Oncology R&D organisation. 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.As an Associate Director and Programming Team Lead (PTL) within the early phase Oncology Statistical Programming group you will lead, direct and line manage a team of programmers as well as the programming work required to deliver on a set of early phase drug projects. You will work collaboratively with both early phase oncology biometrics team leaders and members of those teams, as well as cross functional teams. You will be an integral part of the Oncology Programming group as a member on both the early oncology programming LT and the oncology programming extended LT overseeing and delivering the statistical programming aspects of clinical development,. You will also contribute to managing and maintaining our end-to-end standards, process initiatives and our analysis and reporting production tools. You will provide input into the development of early phase projects and remain accountable for the delivery of the projects/studies within your teams’ remit.The Oncology Programming group oversees and delivers all the programming contributions to internal decision making across phases including regulatory submissions and reporting and commercial activities for the portfolio of drug projects within the Oncology R&D organisation. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.Main Duties and ResponsibilitiesReporting to the Director(Head) within the Early Oncology Programming team you will act as a strategic programming leader, providing support for all aspects of the clinical development process including, but not limited to, CSR delivery/review, BLA submissions, adhoc/exploratory analysis, annual safety reporting, programming and information deliverables and scientific utilization data for AstraZeneca’s early phase oncology products.  You will lead the provision of technical expertise to external partners in relation to the specification and delivery of the SDTM/ADaM databases and outputs by these partners.  This will include overseeing the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable.In this role, you will have accountability for the quality of a drug projects statistical programming work worldwide.  You will also work to improve quality, efficiency and effectiveness by contributing to the development of best practice and identifying opportunities to improve our processes by providing practical solutions to problems.Essential RequirementsBSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life ScienceExtensive SAS programming expertise to an advanced levelComprehensive knowledge of technical and regulatory requirements related to the roleKnowledge of CDSIC standards and industry best practicesExtensive experience in clinical drug development or healthcareExperience in Regulatory submissionsExcellent verbal and written communication skills and influence stakeholdersLead the development and delivery of trainingAdvanced to expert verbal and written communication and collaboration skills.Advanced to expert problem solving and conflict resolution.Drive others to work across global & functional boundaries.Travel – willingness and ability to travel domestically and/or internationally.Ability to apply programming knowledge and skills to problems, problem solving, and quality focus.  Troubleshoots for team.Contributes to defining business processes and accurately completes and manages associated documentation.Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.Diligence – attention to detail and ability to manage concurrent projects and activities within and across those projects.Desirable RequirementsOther programming languages e.g. Python, R, XML etc.Extensive knowledge of Pinnacle 21 Validator,employmentType:Full_time,identifier:R-072265,title:Associate Director Statistical Programming, Early Oncology,url:,hiringOrganization:{@type:Organization,name:AstraZeneca},jobLocation:{@type:Place,address:{@type:PostalAddress,addressLocality:Gaithersburg,addressRegion:Maryland,addressCountry:US,streetAddress:One MedImmune Way;;Gaithersburg, MD 20878;Gaithersburg;Maryland;United States of America,postalCode:}}}

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