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ServiceUpdated 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

  • Development of the trial outline

  • Adequate choice of the trial design including e. g. options of group sequential or adaptive designs

  • Formulation of trial endpoints

  • Formulation of suitable hypotheses for addressing the trial objectives (e. g. superiority, non-inferiority, equivalence)

  • Adequate choice of significance level(s) and power incl. adjustments in case of interim analyses or multiplicity

  • Provision of reliable sample size estimates

  • Writing the statistical section of the trial protocol

  • Generation of the statistical analysis plan

Data Monitoring and Safety Boards (DSMB)

  • Preparation of statistical tables and figures for DSMB sessions

  • Participation as statistical expert in Data Monitoring and Safety Boards

Statistical Analysis & Reporting

  • Programming of analysis files

  • Programming statistical tables and graphs using SAS®

  • Performance of statistical analyses

  • Programme validation

  • Generation of a statistical trial report

  • Statistical contribution to clinical trial report

  • CDISC / ADaM competence

  • CDISC / FDA conform data export

Type

  • Consulting

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