We’re Avance Clinical a Contract Research Organisation.
We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.
Why should you join Avance Clinical?
We appreciate that our most important asset is our people.
We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
We are committed to creating a flexible work setting for our people by supporting them to balance their work commitments and personal needs, both now and into the future.
Role Description
- Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards.
- Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF)
- Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE.
- Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles.
- Review and provide input to Case Report Forms (CRFs) and External Data Review Transfer Agreements.
- Management of project specific programming tasks and deliverables (including maintenance of planning documents and regular communication with internal stakeholders) to ensure project team will provide statistical programming deliverables according to project timelines.
- Provide accurate programming time estimates and risk mitigation plans to Management or Project Team.
- Identify study priorities and communicate effectively with project team and management.
- Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.
- Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient.
- Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
- Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients.
- Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.