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Summary

i look for a job as a Statistical programmer with SAS. i can work for any company that is specialized in Data Management and Statistical Analysis of Clinical trials (or in any CRO) . i can work as well from home at Freelance base as in an office in antwerp or in the nearby towns in belgium.on my profile you will find more concrete details over my experience and expertise.

Experiences

Current Experience

  • Freelance Statistical Analyst Programmer with SAS


    Since March 2011
    i create custom reports using SAS, populate tables with processed data, provide Statistical Analysis for different parts of Clinical trials, convert raw data from different sources to SAS datasets, etc I create custom reports using SAS, populate tables with processed data, provide statistical analysis for different parts of clinical trials, convert raw data from different sources to SAS datasets, etc

Past Experience

  • Administratief medewerker

    August 2007 --- September 2008

  • CEO and Project co-ordinator for OSI

    November 2003 --- August 2007

  • Sales Manager

    September 2001 --- October 2003

  • Administratief Directeur

    August 1998 --- July 2001

Personality

Self Assessment :
Analytical thinkingIndependenceImpulse commandCritical thinkingSelf-disciplineSelf-confidenceWillingness to compromiseTrustEfficiencyAttention to detailAuthenticityInterest in knowledge

Knowledge

Self Assessment :
CDISCClinical Data Management (CDM)Clinical researchClinical trialsData AnalysisData cleaningData entryData ManagementDatabase design and maintenanceDrug safety assessmentFDA Phase IEnglishICH-GCPMicrosoft ExcelMicrosoft OfficePharmaceutical IndustryPharmacodynamicsPharmacokineticsPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)New Drug Application (NDA)ProtocolSerious Adverse Event (SAE)Statistical considerations in design and analysisStatisticsValidationUnderstanding of regulatory guidelinesUnderstand levels of research evidenceUnderstand how results translate to practiceTeam LeadershipSOPProgrammingProduct launchProduct designEDCClinical trial design
LinkedIn Assessment :
Microsoft WindowsMicrosoft OfficeSASSQLXLSTATStatisticsClinical trialsData ManagementData AnalysisCROPharmaceutical IndustryPR and media contactsMarketingSocial MediaAdvocacy

Skills and Expertise

Self Assessment :
Document data collection systemlifescienceDocument data reporting systemsManage clinical trial files/documentsDocument employees training requirementsmanaging a small teamdrafting grant applicationsMonitor dataEnsure data consistencyNetworkEnsure data integrityObserve trends in dataEnsure good clinical practice (GCP)Obtain grantsFinancial administrationOffice managementFinancial reportsOral presentationGeneral office managementPrepare final reportGenerate regulatory submissions Present clinical resultsGuide staffPresent data at congressInteract with CROsProject probable outcomesInteract with pharmacistsQuality control processInteract with physiciansReport dataInteract with pre-clinical scientistsReport study conclusionsInterpret dataRetrieve study documentsLabeling compliance with local regulationsReview clinical study reportsLate-stage regulatory filing (MAA, BLA)Review data interpretationLiaise with doctorsReview exclusion criteriaLiaise with research teamReview inclusion criterialifescienceReview manufacturing documentationManage clinical trial files/documentsReview quality control activitiesmanaging a small teamReview monitoring reportsMonitor dataReview quality policiesNetworkReview queriesObserve trends in dataReview study protocolsObtain grantsReview vendor metricsOffice managementReview vendor reportsOral presentationSearch literature on clinical trialsPrepare final reportSolve problemsPresent clinical resultsStatistical analysisPresent data at congressStudy execution planProject probable outcomesStudy-related documentsQuality control processSupervise data processingReport dataTranslate clinical research concepts into specific objectivesReport study conclusionsTranslate protocol into packaging and labeling requirementsRetrieve study documentsValidate dataReview clinical study reportsVerify dataReview data interpretationWork under specific instructionsReview exclusion criteriawrite and maintain clinical evaluation reportsReview inclusion criteriaWrite clinical evaluation reportsReview manufacturing documentationReview quality control activitiesReview monitoring reportsReview quality policiesReview queriesReview study protocolsReview vendor metricsReview vendor reportsSearch literature on clinical trialsSolve problemsStatistical analysisStudy execution planStudy-related documentsSupervise data processingTranslate clinical research concepts into specific objectivesTranslate protocol into packaging and labeling requirementsValidate dataVerify dataWork under specific instructionswrite and maintain clinical evaluation reportsWrite clinical evaluation reportsSolve problemsControl dataStatistical analysisCreate clinical documents Analyze dataStudy execution planCreate study documents Interpret dataStudy-related documentsData coding Report dataSupervise data processingData entry Search literature on clinical trialsTranslate clinical research concepts into specific objectivesData validation Write papersTranslate protocol into packaging and labeling requirementsData verification Use content management systemsValidate dataDesign database Administrative supportVerify dataDesign study documentsAdverse event reportingWork under specific instructionsDocument adverse eventsArchive documentationwrite and maintain clinical evaluation reportsDocument data collection systemArchive study documentsWrite clinical evaluation reportsDocument data reporting systemsAssess adverse reactionsWritten presentationDocument employees training requirementsWrite papersdrafting grant applicationsClinical data collectionEnsure data consistencyCollaborate with medical teamEnsure data integrityCollaborate with principal investigatorEnsure good clinical practice (GCP)Collaborate with project teamFinancial administrationCollect patient forms and questionnairesFinancial reportsCommunicate with investigatorGeneral office managementCommunicate with sponsorGenerate regulatory submissions Control dataGuide staffCreate clinical documentsInteract with CROsCreate study documentsInteract with pharmacistsData codingInteract with physiciansData entryInteract with pre-clinical scientistsData validationInterpret dataData verificationLabeling compliance with local regulationsDesign database Late-stage regulatory filing (MAA, BLA)Design study documentsLiaise with doctorsDocument adverse eventsLiaise with research team

Education

  • Master's degree in Geologie from St. Ivan Rilski universiteit in Sofia, Bulgarije in 1998
  • Bachelor's degree in Internationale economische relaties from St. Ivan Rilski universiteit in Sofia, Bulgarije in 1996
  • Diploma middelbaar onderwijs in ASO Moderne talen – Engels met gelijkwaardigheidsattest van NARIC from Georgi Kirkov, Plovdiv, Bulgarije in 1991

Languages

BrightOwl Assessment:
Self Assessment:
Bulgarian
Native
Dutch
Full Proficiency
English
Professional Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    full time - 40 hours per week Hours per week
  • International:
    Yes

Area / Region

Antwerp, Belgium

Others

Driving License
  • No

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