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Associate Director, Statistical Programming Oncology

Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

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 Oncology Programming department you will lead, direct and line manage a team of programmers along with the programming work required to deliver the requirements of a drug project(s). You will work collaboratively with both biometrics drug project team leaders and members along with cross functional teams. You will be an integral part of the Oncology Programming department that oversees and delivers the programming aspects of clinical development, manages and maintains our end-to-end standards and our analysis and reporting production tools. You will provide support for regulatory submissions including development of the submission strategy, delivering according to that strategy (CSR/HLD databases and outputs) and responses to regulatory questions.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 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 a Senior Director within the Oncology Programming department you will act as the strategic programming leader providing support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialisation and scientific utilisation data for AstraZeneca’s 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 project(s) 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 Requirements

  • BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science
  • Extensive SAS programming expertise to an advanced level
  • Comprehensive knowledge of technical and regulatory requirements related to the role
  • Knowledge of CDSIC standards and industry best practices
  • Extensive experience in clinical drug development or healthcare
  • Experience in Regulatory submissions
  • Excellent verbal and written communication skills and influence stakeholders
  • Lead the development and delivery of training
  • Advanced 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: prioritise 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 those projects.
  • Desirable Requirements
  • Other programming languages e.g. S-PLUS, R, XML etc.
  • Extensive knowledge of Pinnacle 21 Validator
  • The level of the position will be determined by the candidates experience, skills and abilities.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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