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Premier Research Group Limited
,
Reading, Berkshire
Senior Biostatistician
Overview
Job Description
Description 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 Experience: * 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)