Werken bij Rosemind consulting b.v.

Rosemind consulting b.v.

Soort organisatie
Zakelijke dienstverlening
Almere Stad, Almere
Aantal medewerkers
Internationaal actief
Jaar van oprichting
100.000 - 500.000

Wie zijn wij?

Het verrichten van werkzaamheden en het verlenen van consultancydiensten op het gebied van outplacement, uitzenden en detacheren van werknemers, training en coaching alsmede project- en interim management

Kernwaarden en activiteiten



Job Purpose:To provide statistical expertise to support different clinical trial designs in a top bio-pharmaceutical company. Key Responsibilities:Responsible for a whole study from design to execution for different study designs: - Use stat methodology to establish study strategy (e.g.  power modelling of different scenario, set up power monitoring, set up mitigation plan to minimize risk of stat failure) - Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)- Provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)- Develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review - Review the TFL, to coordinate review with the stat analyst, to approve the TFL- Do the QC of the statistical analysis methodology- Validate study specific dataset & analysis program specification - Approve deviation from TFL format - Propose SAR conclusion- Prepare answer to study specific stat question (e.g. inspection, RA question) Key Requirements:‚Äč- PhD, MS or Diploma in Statistics, Mathematics or Epidemiology or equivalent Area.- Experience in SAS software and sample size computation for standard designs- Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood 9 dagen geleden
Senior SAS Programmer
Key ResponsibilitiesProvide SAS programming support (i.e. Writing technical specifications, Developing, Maintenance, validation) for programs that support monitoring, data management and data standards for clinical trial data.Use other tools (e.g. PL/SQL, Cognos, Web technologies) to create programs when appropriate (and when skilled with the tool).Provide direct global user support and trainings and troubleshoot problems on Standards programs.Provide professional programming input for new program or program enhancement requestsAct as data conversion programmer (mainly for SDTM data conversion).May work as independent programmer on standard programs or as part of a team under supervision of a team leader on large and complex projects.Support programming for process improvement projects and may act as Subject Matter Experts in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections. Language skillsFluent English (spoken and written) Soft skillsGood analytical skillsGood interpersonal and communication skillsGood analytical, problem solving, change management and project delivery skillsAccurate worker with attention to details Hard skillsExcellent programming skills in SAS is required, skills with other relevant tools is desiredGood knowledge of CDISC Standards (CDASH, SDTM)Proven ability to objectively review vendor software to maintain effectiveness in rapidly changing IT environment, ability to participate in external Pharma groups on standard programming related matters (e.g., CDISC)Strong knowledge / experience in IT tools, statistical software. and validation methodologyAbility to understand how to apply regulations including ICH-GCP to the area under responsibilityBasic  understanding of clinical data 30+ dagen geleden

Rosemind consulting b.v.
Almere Stad

yi.zhang (rosemindconsulting)

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