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.

Job Dimensions

  • 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.