- Datapharm Australia is a leading local contract research organisation (CRO) providing clinical trial management and statistical analysis for local and global pharma and biotech companies. Datapharm, established in 1987, has a strong reputation in the industry for quality and excellence in its statistical services.
- As a new biostatistician joining the Datapharm team, you will have access to training to expand your skills set and the opportunity to take on a leadership role in the industry.
- Datapharm is a family friendly workplace, and will consider full and part-time positions, home-based interstate and office-based Sydney positions, and commencing while finalising your degree.
The role will involve the following tasks:
Providing important statistical advice to biotech and pharma clients planning clinical trials
- Clinical trial study design and methodology for new protocols
- Sample size calculations
- Setting up randomisation code lists
- Writing statistical analysis plans (SAPs)
- Performing statistical analysis of clinical trial data using SAS
- Programming statistical report tables, graphs and listings
- Writing the statistical results sections of the clinical study report (CSR)
- Providing reports and attending DSMB meetings if required
- SAS programming to support clinical data management processes including producing data listings in ICH E3 format for the CSR App 16.2
- Converting data sets to CDISC/ADAM format for regulatory submissions.
- Providing advice inhouse to project teams
- Actively participating in statistical forums in the industry and keep up to date with relevant regulatory requirements
Essential: Must have:
- Postgraduate qualifications in statistics – preferably Masters in Biostatistics or PhD with Statistics major and Life Science Background
- Experience in biostatistics preferably with clinical trial analysis
- Experienced in programming in SAS, R and other software
- Familiarity with ICH guidelines and other regulatory requirements
- Excellent written skills to allow for writing clinical study reports
- Eye for detail and accuracy and emphasis on the importance of quality
- Strong communication skills for client presentations and training the team
- Enthusiasm and willingness to co-operate with others in a busy interactive and interdependent team
- Good time management and organisational skills and ability to meet deadlines.
Datapharm Australia Pty Ltd is a contract research organisation (CRO) (www.datapharmaustralia.com ). Datapharm provides support to pharmaceutical and biotechnology companies in clinical research by setting up and monitoring clinical trials, collecting and analysing the data from these studies. Its statisticians provide study design, statistical analysis and reports for many clinical studies each year. The statistical analyses, CSRs and data sets are often included in regulatory submissions to FDA, EMA and TGA.
Other: You must have the right to live and work in Australia to apply for this job. Datapharm reserves the right not to proceed with any appointment.
Salary will be negotiated according to experience and qualifications.