If interested please contact Martin Grindrod at
[log in to unmask] or on the contact
numbers given in the job description. Please do
not respond to this email address.



Hays Pharma are seeking to recruit an experienced
Oncology Statistician to manage statistical
activities within the oncology group within this
global pharmaceutical company. This role covers all phases (I-IV).


TASKS INCLUDE:

* Take responsibility as a statistical
adviser to clinical study teams in oncology, and
make contributions to the statistical effort in
other therapeutic areas as required

* To ensure that, in conjunction with
Medical Sciences, and other groups (eg
Pharmacokinetics) clinical development plans have
a high quality, timely and robust statistical input.

* To ensure that clinical study protocols
are developed with statistical input as early as possible.

* To take responsibility for ensuring that
outsourcing of statistical projects is conducted
after a thorough evaluation of the statistical
capabilities of the CRO concerned.

* To ensure that the Clinical Research
Manager has the functional specifications,
quality standards and statistical input to the
CRO evaluation and management process in a time
frame and in accordance with clinical study team outsourcing strategy.

* To co-ordinate the clinical research
components of regulatory activities with respect
to statistical methods, results and evaluation in
such a way as to eliminate the chances of
unsuccessful regulatory submissions. To provide
the written and verbal elements of regulatory submissions around the world.

* To present statistical methods used in
clinical studies to Regulatory bodies when
required : this includes the FDA and EMEA as well
as national bodies as appropriate.

* To manage the biostatistical input to the
regulatory review process, addressing Regulatory
bodies questions in a timely technically sound and clearly presented manner.

* To plan, schedule and track all
statistical activities, to ensure high quality,
timely and accurate completion of statistical deliverables
Where necessary, to supervise permanent or contract staff.


SKILLS & EXPERIENCE:

§ Degree and Post-graduate qualification (M.Sc, PhD etc) in Statistics
§ Significant clinical statistics
experience within a pharmaceutical Company (preferable) or CRO
§ Good understanding of the requirements of GCP and ICH guidelines
§ Experience of successful involvement in MAA/NDA processes
§ Ability to present statistical issues in
a clear, logical and non-technical manner to
differing audiences (statistical,
non-statistical) at all levels within the organisation.
§ Excellent organisational and communication skills
§ Pro-active business focused approach
§ Ability to work within a
multidisciplinary team, preferably international, and be pragmatic
§ Good experience of participating in selection and management of CRO
§ Fluent in English
§ Experience of using statistical software (SAS, etc.)
§ Familiarity with drug development in the oncology therapy area.


If you would like to discuss this position in
detail, or for a confidential consultation on all
of our current Biostatistics and Programming
opportunities in the UK and Europe, please
contact me directly. Details of our current
contract and permanent vacancies can also be
found at our new website - www.hayspharma.com.

Kind Regards,

Martin

Martin Grindrod
Senior Consultant, Biostatistics - Hays Pharma
t. +44 (0) 20 7922 7128
f. +44 (0) 20 7922 7101
m.+44 (0) 7884 001300

Hays Pharma is part of the Hays Plc group of
companies - for all our latest jobs and industry news go to www.hayspharma.com.

Hays Pharma - formerly James Harvard Pharma, for
further information please go to http://www.hayspharma.com/press_release.php

P Please consider the environment before printing this e-mail
Hays Pharma is proud to be a Carbon Neutral
Company http://www.carbonneutral.com/




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#####################################
James Miller
Department of Statistics
University of Glasgow
15 University Gardens
G12 8QQ
0141 3302474
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