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Senior Statistician

11/09/2019
- Leuven

Job content

As Senior Statistician you will report to the Director of Biostatistics.

Preferably, you will work Office-based but working Home-based is possible. 

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
Profile

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)
  • experience as senior staff member/teamlead

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
What do we offer?

We offer a direct position with our client. 

Contact

For more information, contact Marieke Franken +32 16 30 95 09