AstraZeneca Pharmaceuticals LP Principal Programmer in Warsaw, Poland

Candidate Focus & Challenge

Act as the technical leader or subject matter expert for the department, therapeutic area, or drug project in one or more of the following areas:

  • Lead 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.

  • The creation of regulatory deliverables including but not limited to:

  • Regulatory response to agency queries

  • Development Safety Update Reports (DSUR)

  • Periodic Benefit-Risk Evaluation Report (PBRER)

  • Investigators brochures (IB)

  • Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies

  • Etc.

  • Therapeutic area specific analyses

  • Outcomes studies/outcomes management

  • Payer research/reimbursement

  • Standards, e.g., CDISC, Astra Zeneca, governance MDR principles

  • Data preparation and analysis for Global Medical Affairs work

  • Pharmacokinetics/pharmacodynamics data preparation and analysis

  • Manipulating and analyzing adjudicated data

  • Planning and executing the transfer and analysis of data for data safety monitoring boards/independent data monitoring committees

  • Planning and delivering Clinical Trial Transparency (data de-identification)

  • Work with the Statisticians to create the randomization schedules for the clinical trials

  • Other areas as assigned

Candidate Knowledge, Skills & Experience

  • Values:

  • Able to leverage experience to innovate and streamline workflows

  • Knowledgeable of the drug indications within a therapeutic area, their analysis trends, and their effects on data submission standards.

or

Knowledgeable of architecture and/or utilization of a programming language and how to best use it for department, TA, or drug product

  • Able to effectively assess and mitigate risk within a task and proactively determine the need and/or level of escalation

  • 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 pactices

  • Subject matter expert in one or more areas of programming within clinical drug development.

  • Excellent verbal and written communication skills

  • Assist in developing and delivering training in areas of expertise

Job Dimensions

  • Leadership role, able to lead and direct elements of department, therapeutic area, or project work

  • Accountable for the quality of elements of project programming work worldwide

  • Accountable for Good Information Practice

Other

  • Behaviours:

  • 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. Be proactive Excellent collaboration required – needs the energy to work across global & functional boundaries

  • Decision making: constructively challenge others and be receptive to challenge in bringing clarity and robustness (evidence based) to decision making within the team

  • Issue resolution: work collaboratively with the project team to resolve issues, irrespective of whether or not the issues are functional in nature

  • Communication: agree on how to communicate decisions, successes and escalation of issues etc – speak with one voice instead of separate roles.

  • Excellent collaboration required – will work across the department or a therapeutic area.

  • Ability to apply programming expertise to problems, problem solving and quality focus.

  • Other programming languages e.g. S-PLUS, R, XML etc.

  • Extensive knowledge of Open CDISC Validator