Position at Premier Research Group Limited
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality.
We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and paediatric research.
We’re looking for a talented and energetic Senior Statistician to join our team!
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.
You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
Our Biostatisticians apply knowledge of statistics to independently provide statistical consulting, assist with study design and protocol development, performs statistical analysis of clinical trials.
They will also review project related documents, prepare statistical analysis plans (SAPs) and statistical reports. This individual will develop analysis data specifications, create analysis datasets, Tables, Listings and Graphs (TLG) of clinical trial data using SAS.
He or she will also perform quality control of TLGs and derived data sets created by others. Develop and validate SAS programs, micros, and utility tools.
Apply advanced programming knowledge to support programming efficiencies.
You'll be accountable for :
Independently providing statistical consulting
Preparing statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specifications
Reviewing protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
Independently developing statistical analysis plans (SAP) in accordance with the protocols and SAS programs to develop statistical models and complete statistical analyses
Supporting integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
Independently preparing analysis data specifications
Developing SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
You'll also be Responsible for :
Performing quality control of analysis data and TLGs
Preparing statistical reports
Reviewing, providing input and interpreting of analysis result to clinical study report
You'll Need this Background to be Considered :
Educational Background :
Advanced degree (MS or PhD, or equivalent) in statistics or closely related field
Direct advanced knowledge of clinical trials design and analysis experience with advanced SAS programming experience
Working knowledge of CDISC standards and application of those standards to projects
Personal skills & behaviours :
Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
Detail oriented, well organized
Ability to work on several projects simultaneously
Demonstrated knowledge of design of clinical trials and regulatory requirements
Demonstrated working knowledge of advanced SAS macro development and code generation / management algorithms
Knowledge of design of clinical trials and regulatory requirements
Excellent English communication skills (verbal, written & interpersonal)