Your Partner for Biometrics and SAS Programming in clinical research
WHAT I offer
As professional in the area of biometrics and SAS programming in clinical research I support you performing Phase I to IV Studies, Non-Interventional Studies and Investigator-Initiated Studies. I help you with data mining projects and preparing postersessions and plubications.
My offer comprises consultancy concerning study design, sample size calculation and statistical methodology, creation of analysis datasets, efficacy- and safety analyses as well as explorative evaluations.
I assist you in submission activities and ensure compliance with regulatory standards (CDISC).
If you need an independent reviewer for your validation process , I conduct SAP review as well as double programming and review of tables, listings and figures with respect to content, form and consistency.
My service also covers portions of data management and consultancy concerning programming and process optimization or implementation of CDISC standards. For larger programming projects I can act as lead and coordinate and organize the programming activities.
You can read more about my range of services here
HOW I work
Clinical research is subject to the GCP and ICH guidelines. This demands processes granting high quality and traceability.
Accuracy, detailed documentation, consistent data handling, definition of a QC-plan and independent review are therefore substantial elements of my processes.
I am continuously staying in close contact with my clients to ensure that I stick to required processes and standards and to discuss relevant aspects of the project.
In order to offer comprehensive and professional services I work closely together with my business associates from life science area.
This way I can adapt quickly and flexibly to your needs. This means that you can pass complete projects or I support directly your team when extra help is needed for meeting tight deadlines. Contact me to discuss how I can support you.
WHY you may need my service
If you have a lack of resources I can fill the gap. There are many reasons why you may need assistance: unexpected workload, temporary leave of an employee, there is no suitable candidate for a vaccancy, there is only little or no experience on a certain topic etc.
Whatever is the reason just contact me.
WHO I am
20 years of experience as a statistician and programmer in life science. This experience includes:
- Clinical research – from the planning stage to evaluation and submission
- SAS BASE, STAT, GRAPH, SAS Macro Programming
- Cooperation with international pharmaceutical corporations and numerous CROs
- Oncology studies
- Quality management in the treatment of chronic diseases
Core competencies: SAS programming, statistics, CDISC (SDTM, ADaM, define.xml)
I regularly participate in seminars, conferences and workshops to keep up with the latest developments.
But most of all I learn in my daily work and in the cooperation and discussion with the highly qualified and experienced experts of my clients. That's what I like most about my work, you keep on learning. Clinical research has so many faces, depending on study phase and type and indication new challenges are waiting.