Senior Statistician

Senior Statistician

PSI CRO

Leuven, Belgium

Reporting to the Director of Biostatistics, the Senior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!

Job Description

Primary 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.

Corporate/Departmental Assignments:

  • Participation in bid defense meetings and kick-off meetings;
  • Communication line for project teams, including statisticians and SAS Programmers;
  • Communication line for customer on statistical questions;
  • Communication line for vendors on statistical questions.

Training:

  • Conduct of project-specific training of statisticians and SAS programmers;
  • Coaching and training of statisticians (non-project-related);
  • Preparation and delivery of presentations at investigators' meetings.

Quality Assurance:

  • 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

Minimum Education:

  • MSc in Statistics or equivalent.

Experience:

  • Strong industry experience in clinical research, 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, define 1-0-0.xml and define 2-0-0.xml specifications;
  • Knowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plus.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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