B&I Senior Programmer (SAS)
Short role description
- Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making. B&I’s goal is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
- Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.
- TA Programming is the business unit that oversees and delivers all the statistical programming contributions to internal decision making, regulatory submissions, and reporting and commercial activities for a therapy area (TA) portfolio of projects.
- Standards & Business Solutions (SBS) is the business unit that develops and maintains end-to-end clinical data standards, leads and contributes to B&I’s process and infrastructure initiatives, and provides cross-TA Biometrics deliverables, resources, and support to late-stage drug project teams
- As a member of TA Programming or Standards & Business Solutions, collaborates with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to the following:
-Data submission strategy (e.g., managing legacy data, pooling data)
-Responses to regulatory agency queries
-Tables Figures and Listings (TFLs)
-Development Safety Update Reports (DSURs)
-Periodic Benefit-Risk Evaluation Reports (PBRERs)
-Investigators brochures (IBs)
-Office of Scientific Investigations (OSI) data sets and listings
-Regulatory and/or Payer submission related analysis data sets and/or TFLs
-Associated quality and process documentation as per applicable business processes
Collaborates with the Programming Leader to provide programming support to deliver technical programming and information components of a study, including but not limited to the following:
-Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
-Tables Figures and Listings (TFLs)
-Pharmacokinetics/pharmacodynamics data preparation and analysis
-Manipulating and analyzing adjudicated data
-Data preparation and analysis for Global Medical Affairs work
-Clinical Trial Transparency deliverables (data de-identification, results posting files)
- Collaborates with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for AZ products.
- Produce and maintain the technical database standards and Programming Specification documents.
- Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners.
- Provide support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions.
- Contributes to the development of best practice to improve quality, efficiency and effectiveness.
- BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
- Extensive SAS programming knowledge and experience.
- Knowledge of database set-up and report publishing requirements.
- Knowledge of technical and regulatory requirements related to the role.
- Knowledge of CDSIC standard (e.g., CDASH, SDTM, ADaM) and industry best practices.
- Knowledge and experience of clinical drug development or healthcare.
- Excellent verbal and written communication skills.
- Assist in developing and delivering training.
- Able to demonstrate team working and role leadership skills appropriate to level.
- Advanced verbal and written communication and collaboration skills.
- Competent to advanced problem solving and conflict resolution.
- Needs the energy 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.
- 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.
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.