Dear Allstat,
CK Clinical is currently recruiting for a Biostatistician to work for a
leading Pharmaceutical organisation in Germany. Your primary
responsibility will be to work as a statistician in the clinical
development of new drugs - starting from phase I up to registration and
launch. The position involves working closely with physicians, data
managers and programmers in international project and study teams.
Your responsibilities as a Study Statistician (Phase I - IIIb):
* Planning and decision making for state-of-the-art study designs,
evaluating methods and performing sample size calculations
* Developing study protocols in collaboration with study physicians
* Participating in the monitoring of study conduct to oversee data
quality and potential implications for the planned analysis
* Responsibility for study evaluation and reporting through creation of
a statistical analysis plan, performing the inferential statistical
analysis
* Writing integrated reports and scientific publications in
collaboration with the study physician and medical writer
* Planning statistical aspects of clinical development plans, in close
collaboration with the medical project leader and other members of the
global project team
* Providing answers to project related statistical or methodological
questions from decision-makers inside and outside the company
* Writing detailed statistical project plans and stipulating
requirements and standards for study teams
* Providing guidance to study statisticians on protocol development,
analysis plans, study reports and publications
* Planning and compiling clinical registration dossiers
* Preparing regulatory documentation for the EU and the USA, in
collaboration with project physicians and data managers
* Discussing statistical issues with drug regulators
Interested applicants will have an MSc or PhD degree in Statistics or
Mathematics (Or equivalent) as well as a comprehensive knowledge of
Biostatistics. You should also be familiar with the application of new
statistical methods and theories in software solutions involving SAS or
R. Experience as a project or study statistician in clinical development
is considered a major advantage.
You will be expected to be self motivated, a good communicator and team
player, have a firm grasp of the English language, and enjoy working on
challenging scientific projects and studies in an international setting.
For a confidential discussion or further information, please contact me
on +44(0)1438 870028 or email an updated copy of your CV to
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CK Clinical is a leading clinical recruitment company handling jobs in
clinical research and drug development. Our clients include some of the
top Pharmaceutical and Biotechnology companies from around the world and
our reputation for honesty and integrity is well known. We offer
contract and permanent job opportunities within Clinical Research,
Biometrics, PVG, Regulatory Affairs and Medical Affairs to experienced
professionals and entry level candidates.
For more information about our services and the jobs that we can help
with please look at our website www.ckclinical.co.uk
I look forward to hearing from you.
Best regards,
Priya
Priya Mukherjee BSc (Hons) MIRP CertRP
Senior Consultant
CK Clinical Limited
9 High Street
Stevenage Old Town
Hertfordshire
SG1 3BG
DD: +44 (0)1438 870028
Mobile: +44 (0) 7714 288632
Tel: +44 (0)1438 743047
Fax:+44 (0)1438 723800
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