I am Rainer Grauf, a statistical programmer with two decades of experience in pharmaceutical research, both in CROs and pharmaceutical industry. Good statistical background (MSc in Applied Statistics). Mentored a team of programmers in India who were working in a dedicated team for a global US-based pharmaceutical company.
Metronomia Clinical Research GmbH (Munich) – Derives complex analysis datasets. Creates tables, figures and listings for efficacy and safety evaluation. Performs QC of analysis datasets. Therapeutic areas: Oncology, Neurology.
Mentor of a sponsor-dedicated team of 20-30 programmers. Increased the skills level of the team both in the areas of technical capabilities and soft skills:
Statistical programmer / consultant – Generated pooled databases and analyzed phase II and III studies (therapeutic areas: Asthma, allergies).
Statistical programmer / consultant – Generated integrated safety summaries for submission to regulatory authorities. Generated project-specific databases for pooled safety and efficacy analyses and data transfer to FDA. Reviewed publications and reports with regards to statistical issues. Reviewed analysis plans. Therapeutic areas: Organ transplantation, invasive fungal infections, dermatology, urology (studies of phases I-IV, submission documents).
Statistical programmer / consultant – Performed datamanagement and statistical analyses as in the previously held permanent position, in addition to distance learning studies in applied statistics at Sheffield Hallam University.
Verum – Staticon European Clinical Development – As statistical programmer in a permanent position: Performed datamanagement (based on SAS-applications, and also on Clintrial), analysed data of clinical studies (phase II-IV) and observational studies within a wide range of therapeutical areas, using SAS.
Sheffield Hallam University (UK) :MSC Applied Statistics
Bavarian Institute for Soil Science and Plant Breeding: Dr. agr.
Technische Universität München: Dipl. Ing. agr./ MSc Agronomy