AstraZeneca Pharmaceuticals LP Senior Programmer in Warsaw, Poland
Candidate Focus & Challenge
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.
Candidate Knowledge, Skills & Experience
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.
Lead the quality of own programming work and aspects of the team's as well as the completeness of applicable quality and process documentation.
Accountable for good Information Practice on all assigned activities.
When deployed to a B&I drug project team, operates under the leadership, direction and oversight of a Global Project Programmer (GPP) or her/his delegate.
Other Qualifications & Capabilities
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.