AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
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
- 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
- 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