Senior Statistician / Project Lead

Senior Statisticians / Project Leads

Ashley Clarke @ RBW consulting is currently recruiting for a Senior / Principal Statisticians to work for a small European CRO who works with the worlds’ leading biotech sponsors.  

They pride themselves on their ability to deliver on time and strive to be the best. In turn they look for the same qualities in their employees, they want to work with professionals who want to make a difference and take pride in the their work. With over 25 years clinical trials experience and growing, they are clearly doing all the right things.

Overview

Senior Statistician / Project leads is an integral part of our team, especially in this very busy market. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods I would encourage you to apply and start a conversation me.

Responsibilities

• Lead all biostatistics activities related to clinical trials as responsible project statistician
• Communicate with project teams, clients and vendors on statistical questions
• Develop and review statistical sections of protocols, including sample size calculations
• Develop statistical analysis plans
• Develop and document analysis database structures (i.e. SAS analysis data set structures)
• Develop SAS program requirements and specifications
• SAS programming and program validation
• Review and QC of statistical deliverables (tables, listings, figures, etc.)
• Perform statistical analysis and report results
• Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
• Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
• Participate in bid defence meetings and kick-off meetings
• Train statisticians and SAS programmers
• Prepare and deliver presentations at investigators' meetings
• Address audits findings/recommendations, and follow-up on and resolution of audit findings
• Participate in the development of guidelines, procedures

Requirements

• MSc in Statistics or equivalent
• Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
• Knowledge and understanding of the SAS programming language; advanced knowledge of SAS software
• Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
• Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
• Strong knowledge of CDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xml specifications
• Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Presentation and communication skills
• Ability to work in English 

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.