Statistical Analysis Developer Clinical Research

5 days ago


Sydney, New South Wales, Australia Avance Clinical Pty Full time

Are you a seasoned statistical programmer looking for a new challenge? We invite applications from highly skilled professionals to join our dynamic team at Avance Clinical, a leading Contract Research Organisation (CRO) based in Australia.

About the Position

This is an excellent opportunity for a motivated and experienced statistical programmer to take on the role of managing complex clinical trial data and developing innovative solutions.

Key Responsibilities

The successful candidate will have expertise in 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.

Qualifications

  • 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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