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.
Experience
2017 – Present Senior statistical programmer
Self employed
2013 – 2017 Metronomia Clinical Research GmbH
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.
SIRO Clinpharm Pvt. Ltd. (Mumbai/India)
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:
- Conducted trainings on various topics (programming techniques, concepts of clinical studies, sponsor’s standards, understanding customer’s expectations, efficient communication, ownership attitude, responsibility of individuals for planning).
- Supported projects in critical situations.
- Initiated improvements of existing work streams with respect to quality, timeliness and efficiency by means of standardization, channeling of communication, description of processes in documents.
- Contributed to development of new work streams in cooperation with the sponsor.
2006 – 2008 Kendle GmbH Munich
Statistical programmer / consultant – Generated pooled databases and analyzed phase II and III studies (therapeutic areas: Asthma, allergies).
2001 – 2007 Fujisawa/Astellas GmbH Munich
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).
1997 – 2000 Staticon International GmbH
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.
1992 – 1997 Verum
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.
Education
1996 – 1999
Sheffield Hallam University (UK) :MSC Applied Statistics
1987 – 1992
Bavarian Institute for Soil Science and Plant Breeding: Dr. agr.
1981 – 1987
Technische Universität München: Dipl. Ing. agr./ MSc Agronomy