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Senior Statistician Oxford United Kingdom,  

PSI (company)


Posted on : 17 January 2017

Project Description

Description:
We are looking for professional, qualified and enthusiastic candidate to take up a full-time, permanent position as a Senior Statistician role to support our Global Clinical Research teams.


Responsibilities:
  • Leading all biostatistics activities related to clinical trials as responsible project statistician 
  • Communication line for project teams, clients and vendors on statistical questions 
  • Development and review of statistical sections of protocols, including sample size calculations 
  • Development of statistical analysis plans 
  • Development and documentation of analysis database structures (i.e. SAS analysis data set structures) 
  • Development of SAS program requirements and specifications 
  • SAS programming and program validation 
  • Review and QC of statistical deliverables (tables, listings, figures, etc.) 
  • Performing statistical analysis and reporting results 
  • Providing consultation on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products 
  • Liaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics 
  • Participation in bid defense meetings and kick-off meetings 
  • Preparation and delivery of presentations at investigators  meetings 
  • Coaching and training of statisticians and SAS programmers 
  • Preparation for and attendance at internal and third-party study audits pertinent to Statistics 
  • Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings 
  • Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department 



Qualifications: 
  • MSc in Statistics or equivalent 
  • Relevant industry experience in clinical research, including significant experience in biostatistics and SAS programming 
  • Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research 
  • Very Good knowledge and understanding of the SAS programming language 
  • Strong 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 
  • Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies 
  • Strong ability to represent biostatistics in bid defenses 
  • Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH) 



Skills:
  • Excellent presentation and communication skills 
  • Advanced knowledge of SAS software 
  • Good knowledge of MS office software 
  • Advanced knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specifications 
  • Knowledge of CDISC SDTM IG 3.1.3 or later and n Query Adviser software is a plus

Locations

UK OXFORD

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