Short role description

Biometrics Late RIA goal is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and crafting the external environment whilst accessing and implementing innovative solutions.

Programming is the department that leads all aspects of and delivers the programming aspects of clinical drug development, handles and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.

Late RIA Programming is the business unit that coordinates and delivers all the statistical programming contributions to internal decision making, regulatory submissions, and reporting and commercial activities for a RIA therapy area (TA) portfolio of projects.

Typical Accountabilities

As a member of RIA Programming, provides programming support, under supervision, to deliver technical programming and information components of a project, including but not limited to the following:

• 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

Provides programming support, under supervision, 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)
• Clinical Trial Transparency deliverables (data de-identification, results posting files)

Contributes to development of best practice to improve quality, efficiency and effectiveness. Ensures alignment to all applicable AstraZeneca and external requirements.

Job Dimensions

Accountable for the quality of own programming work and completeness of applicable quality and process documentation.

Accountable for good Information Practice on all assigned activities.

When deployed to a Biometrics Late RIA drug project team, operates under the leadership, direction and oversight of a Global Product Programmer (GPP) or her/his delegate

Education, Qualifications, Skills and Experience

Essential

• BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
• Prior relevant knowledge of a statistical or database programming language (preferably SAS).
• Awareness of database set-up and report publishing requirements.
• Awareness of clinical data standards (e.g., CDASH, SDTM, ADaM), clinical trials, and drug development preferred.
• Able to demonstrate team working and role appropriate leadership skills.

Desirable

• Proficient to advanced verbal and written communication and teamwork skills.
• Capable 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 under supervision.
• Ability to understand and enforce to defined business processes and accurately complete and manage associated documentation.
• Team dedication: 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 activities.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.