Clinical Data Specialist Programmer
5 days ago
Avance Clinical is a leading Contract Research Organisation (CRO) based in Australia, dedicated to delivering high-quality services for pharmaceutical and biotechnology companies.
About the RoleThis is an exciting opportunity for a highly skilled statistical programmer to join our dynamic team and contribute to the success of our clients.
Key ResponsibilitiesThe successful candidate will be responsible for translating 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.
- Review and provide input to Case Report Forms (CRFs) and External Data Review Transfer Agreements.
- Management of project specific programming tasks and deliverables 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.
Requirements
- Minimum 3-5 years' experience in statistical programming in pharmaceutical / health research.
- Strong CDISC knowledge and SDTM conversion experience.
- Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.
- Knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.
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