Offer summary

Qualifications:

Ordinary degree in a relevant discipline or equivalent industry experience., Minimum 2 years of experience in statistical programming within the pharmaceutical or health research sector., Strong knowledge of CDISC standards and experience with SDTM conversion., Excellent verbal and written communication skills, along with strong MS Word and Excel proficiency..

Key responsibilities:

Prepare listings, tables, and figures for clinical study reports.

Create and perform quality control on SAS programs for CDISC datasets.

Liaise with Data Management and bioanalytical laboratories regarding data transfer.

Contribute to the development of Avance procedures and manage project-specific statistical programming tasks.

Job description

Position: Senior Statistical Programmer

Full time

Location: Melbourne.

Who are we?

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.

We are looking for a Senior Statistical Programmer to be based in Melbourne.

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 environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

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.
Assists with the preparation of statistical analysis plans (including preparation/review of listing, table and figure shells) and randomization schedules.
Liaising 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 and reliability and the ability to work unsupervised.
Excellent verbal and written communications skills.
Willingness to work in, and be supportive of, a positive and dynamic team culture.

What We Offer