Avance Clinical, a Contract Research Organisation that supports drug development, is seeking a Senior Statistical Programmer to be based anywhere in Australia.
Broad Purpose
The Senior Statistical Programmer is responsible for providing clinical programming expertise in the production of tables, figures and listings for inclusion in clinical study report, creation and quality control (QC) of CDISC datasets and associated documentation, and other summaries of data collected from clinical trials. In addition, the Statistical Programmer will contribute to the development of Avance procedures and be responsible for the management of project specific statistical programming tasks and deliverables.
Core Responsibilities
* Preparation of listings, tables, and figures for clinical study reports.
* Creation of primary and QC SAS programs for CDISC datasets and associated documentation.
* Assist with the preparation of statistical analysis plans (including preparation/review of listing, table and figure shells) and randomization schedules.
* Liaise with Data Management team and bioanalytical laboratories regarding data transfer.
* Maintain and coordinate CDISC standards, ensure maximum reuse of applied standards and involvement in ongoing process improvement initiatives.
* Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation.
* Other duties as directed by Line Management or delegate.
Qualifications, Skills And Experience
* Ordinary degree in the appropriate discipline or appropriate industry experience.
* Minimum 2 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.
* Formal training in SAS programming (desirable).
* Knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.
* Excellent MS Word and Excel skills.
* Excellent time management and organisational skills.
* Demonstrated initiative, trust, reliability and the ability to work unsupervised.
* Excellent verbal and written communication skills.
* Willingness to work in, and be supportive of, a positive and dynamic team culture.
What We Offer
* Stimulating work
* Project diversity
* An intellectual challenge
* An agile & flexible workplace
* Opportunity to progress
* Stability
* Sense of community
* A leadership team working together on a common goal
* Flexible work options
* Great tools / tech to do your job
* A competitive salary & an extra days holiday for your birthday!
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