Statistical Programmer

• Location - Victoria
• Employment Type - Full-Time

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.

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 Statistical Programmer and Senior Statistical Programmer will be 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 and Senior Statistical Programmer will contribute to the development of Avance procedures and be responsible for the management of project specific statistical programming tasks and deliverables. The Senior Statistical Programmer also mentor Avance staff in the above activities.

Core Responsibilities

• 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.
• Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.
• Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• 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.
• Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Actively participate in study team meetings.
• 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.
• Ensuring programming is conducted according to departmental and industry standards.
• Responsible for developing and maintaining good client relationships.
• Contribute to the development and improvement of Avance procedures related to statistical programming.
• Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

Qualifications, Skills and Experience

• At least Bachelor's in the appropriate discipline or appropriate industry experience.
• Minimum 1-2 years' experience in statistical programming in pharmaceutical / health research. (Position – Statistical Programmer)
• Minimum 5 years' experience in statistical programming in pharmaceutical / health research. (Position – Senior Statistical Programmer)
• 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

• Stimulating work
• Project diversity
• An intellectual challenge
• An agile & flexible workplace
• Opportunity to progress
• Stability
• Sense of community
• A leadership team that are 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

What next?

As a growing business we're looking for likeminded people to join us – we hope that's you.

• To join our team please submit your CV & cover letter as one Microsoft Word document