Updated on 3 August 2026
Statistical Consultancy / Planning / Analysis for Clinical Trials
Executive Assistant ǀ Client Manager ǀ Medical Writer at M.A.R.C.O. GmbH & Co. KG - Institute for Clinical Research and Statistics
Düsseldorf, Germany
About
Statistical Consultancy / Planning
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Development of the trial outline
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Adequate choice of the trial design including e. g. options of group sequential or adaptive designs
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Formulation of trial endpoints
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Formulation of suitable hypotheses for addressing the trial objectives (e. g. superiority, non-inferiority, equivalence)
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Adequate choice of significance level(s) and power incl. adjustments in case of interim analyses or multiplicity
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Provision of reliable sample size estimates
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Writing the statistical section of the trial protocol
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Generation of the statistical analysis plan
Data Monitoring and Safety Boards (DSMB)
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Preparation of statistical tables and figures for DSMB sessions
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Participation as statistical expert in Data Monitoring and Safety Boards
Statistical Analysis & Reporting
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Programming of analysis files
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Programming statistical tables and graphs using SAS®
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Performance of statistical analyses
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Programme validation
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Generation of a statistical trial report
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Statistical contribution to clinical trial report
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CDISC / ADaM competence
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CDISC / FDA conform data export
Type
- Consulting
Organisation
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Düsseldorf, Germany