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Summary

Henriët has a broad knowledge on all aspects of the clinical development process. She holds a Master's degree in Biostatistics as well as Epidemiology. She has over 20 years experience in the design, set-up and conduct of clinical trials as well the statistical analysis and the writing of integrated study reports and scientific papers. In addition she has been closely involved in regulatory submissions (FDA and EMEA) Henriët is result-driven, has a good overall view in combination with an eye for detail. She has a pragmatic approach with a 'can do' mentality and great problem solving skills. In addition, she has excellent communication skills and the ability to build internal as well as external relationships. She is known for leadership and getting things done quickly and efficiently. Specialties: Study design, statistical analysis and biometrical aspects of clinical research

Experiences

Current Experience

  • Senior manager biometrics
    Since August 2013

Past Experience

  • BioStatistician
    January 2011 --- August 2013

  • Director
    January 2002 --- August 2013
    Nienhuis MediStat is an independent, professional organisation for the design, biometrical aspects, statistical analysis and reporting of clinical trials. Activities includes consultancy on design of clinical studies, sample size calculation, randomization, statistical analysis and report writing for phase II-IV clinical research.

  • Director Biometrics
    January 1999 --- January 2002
    Overall responsible for the biometrics department. Tasks included start-up of a new department, including Business Development and line management.

  • BioStatistician
    January 1993 --- January 2002
    (Statistical) input on study design and statistical analysis for clinical trials as well as (integrated) report writing

  • CRA / Project Manager
    January 1992 --- January 1993
    Clinical Research Associate and Project Management tasks. Responsible for initiation and conduct of clinical studies.

  • Clinical researcher
    January 1991 --- January 1992
    Epidemiologic and clinical research

  • researcher
    January 1990 --- January 1991
    Clinical research at the Oxford Record Linkage Study

Personality

Self Assessment :
Analytical thinkingAttention to detailApproachabilityCommunicativeCreative thinkingCritical thinkingCuriosityEfficiencyFlexibility

Knowledge

LinkedIn Assessment :
Clinical trialsClinical researchClinical DevelopmentEpidemiologyBusiness DevelopmentStatisticsDatamanagementDesign MethodologyProblem SolvingPragmaticCROGCPICH-GCPPharmaceutical IndustryBiotechnologyCTMSBiostatisticsLifesciencesRegulatory submissionsoncologyDrug DevelopmentmanagementSOPLife SciencesGood Clinical Practice (GCP)U.S. Food and Drug Administration (FDA)Clinical Study DesignElectronic Data Capture (EDC) Clinical monitoringProject Management

Education

  • MSc in Statistics / MSc, Epidemiology from MSc Epidemiology & MSc Statistics in 1998
  • Master of Science (MSc) in Health Sciences / Clinical epidemiology from Radboud University Nijmegen / Clinical Epidemiology in 1991

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Professional Proficiency
German
Professional Proficiency

Area / Region

Schoorl, Netherlands

Others

Driving License
  • No