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
Therapeutic area specific analyses
Outcomes studies/outcomes management
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
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.
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
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
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