Client

The organisation in question is a global operation with affiliates in 26
countries and is seeking to expand its presence in Europe by means of
further internationalisation. They have production sites in seven countries
to supply the world market. They have a specialist knowledge base within the
pain/analgesics TAs as well as CNS and oncology.

Our client markets its products all over the world. At the same time they
in-license products in traditional indications and out-license their own
successful developments. 

In 2004 they employed more than 1,800 people in Germany alone, and
altogether more than 4,800 people world-wide and their products are
available in more than 100 countries worldwide.


Role: Project Biostatistician

In this position you will:

- provide statistical input at the clinical project and study level in
alignment with the overall clinical strategy
- plan, analyse and report the biostatistical part of a clinical project,
including the introduction and implementation of biostatistical methods
- provide input to the clinical part of regulatory documents
- represent the statistical aspects of a project at regulatory authorities
and in the scientific community
- cooperate with Clinical Research Organisations
- recommend resource needs and analysis costs for trials
- work according to ICH-GCP and ICH-biostatistics guidelines
- instruct and supervise Biostatistical SAS-Programmers and Trial
Biostatisticians

You are qualified for this position if

. you have a university degree in mathematics/statistics, biometry or an
equivalent study course
. you are fluent in English, basics in German is of advantage
. you have solid knowledge of biostatistical methods as well as relevant
guidelines
. you have strong practical experience in mathematics/statistics or biometry
. you are familiar with relevant aspects in clinical research and regulatory
processes
. you have an insight in medicine and drug safety in order to optimise
design of studies in co-operation with specialists from other disciplines
beneficial
. you have international and intercultural work experience
. you show strong communication skills and enjoy working in teams
. you have solid knowledge about our key indications and substance classes
as well as the key stakeholders in R&D and neighbouring functions


If you feel that this position is something you would like to proceed with,
please send me through a copy of your most recent CV and a contact number so
that we can set up a mutually agreeable time to discuss.

Kindest regards

Ash
Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma 
Tel              + 44 (0) 208 320 1085
Fax             + 44 (0) 208 320 1087
Mobile         + 44 (0) 783 529 6437          
 
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