Biostatistics Consulting for German Market Access

The statistical groundwork for a successful benefit assessment should ideally begin long before your EMA approval. Once the dossier clock starts ticking, time becomes scarce. Having a clear analytical strategy in place gives you a significant advantage.

I help you assess the statistical feasibility of your benefit assessment from an early stage. This includes evaluating whether your trial data will allow for meaningful subgroup analyses with sufficient precision, and whether indirect comparisons are feasible given the available comparator evidence. If individual patient data can be leveraged for population-adjusted methods, I advise on necessary preparations.

Investing in strategic statistical planning reduces the risk of unpleasant surprises during dossier preparation and positions your submission for the strongest possible outcome.

Module 4 of the AMNOG dossier contains the detailed medical benefit assessment and is scrutinized intensively by the IQWiG. The statistical analyses presented here determine whether your product receives an added benefit rating – and at what level.

I support you with the complete statistical analysis of your clinical study data according to IQWiG methodological standards. This includes derivation of appropriate effect estimates, confidence intervals, and assessment of both statistical significance and clinical relevance. I implement suitable strategies for handling missing data, conduct sensitivity analyses, and perform subgroup analyses in the format expected by the authorities.

The IQWiG places strong emphasis on patient-relevant outcomes and the clinical meaningfulness of observed effects. For continuous endpoints such as symptom scores or quality of life measures, demonstrating statistical significance alone is not sufficient.

I conduct responder analyses based on validated response thresholds and assess whether the magnitude of effect meets the relevance criteria that IQWiG applies when judging the extent of added benefit. This careful translation from statistical results to clinical meaning is often decisive for the outcome of your assessment.

A well-structured statistical analysis plan is the foundation of any successful benefit assessment. I develop comprehensive plans that specify all analyses in advance: efficacy analyses, safety analyses, subgroup analyses, sensitivity analyses, and methods for handling missing data.

For indirect comparisons, I prepare detailed specifications covering the methodological approach and planned sensitivity analyses. Having these documented before the analysis protects against concerns about data-driven decisions and strengthens the credibility of your submission.

Sometimes you need an independent statistical expert to review your work before it goes to the authorities. I provide critical assessment of draft Module 4 sections, statistical analysis plans, indirect comparison reports, and clinical study reports.

My review focuses on methodological rigor, consistency with IQWiG expectations, and identification of potential weaknesses. I provide concrete recommendations and help you anticipate critical questions before they arise.

After the IQWiG publishes its preliminary assessment, you have the opportunity to respond with a written statement and participate in an oral hearing before the G-BA. These are critical moments where statistical arguments can make the difference.

I support you in preparing the statistical sections of your written response – addressing methodological criticism, providing additional analyses, and formulating clear counterarguments. I also participate directly in oral hearings as your statistical expert, presenting and defending the methodology of your analyses in front of the G-BA committee.

Many pharmaceutical companies partner with Contract Research Organizations for their benefit assessment dossiers. However, there is significant value in complementing this with independent statistical expertise.

As a freelance biostatistician, I offer a perspective that is solely focused on methodological rigor. I have no organizational incentive to minimize scope or avoid difficult statistical questions. This independence is particularly valuable for identifying methodological vulnerabilities before they surface during the IQWiG assessment, for quality assurance of statistical outputs produced by your CRO, and for providing specialized expertise in areas such as indirect comparisons.

I work collaboratively with CROs rather than in competition. Whether as a reviewer, an advisor, or a hands-on analyst for specific components, I integrate flexibly into your existing team structure.