Dear All,

'DATATECH PHARMACEUTICAL' have the following position...

*BIOSTATISTICS MANAGER
*BASED IN: UK-CAMBRIDESHIRE

An exciting opportunity for an experienced biostatisitician looking to increase
study management responsibility within an innovative pharmaceutical
organisation.

Key responsibilities include:-

Ensuring all statistical aspects of documentation pertaining to individual clinical
studies meet required standards and are statistically correct
Ensuring all statistical aspects of documentation pertaining to non-
registrational activities meet required standards and are statistically correct
Function as a Study Statistician
Participate in study team meetings
Project-manage all study team activities within Biostatistics according to
agreed resource and timeline plans
Create statistical text for study concept documents and protocols study
design endpoints sample size methods for analysis
Review and approve randomization specifications
Create statistical analysis plans
Create templates for tables listings and graphs
Review and approve SDF dataset specifications
Review and approve key study-related documents produced by other
functions eg CRFs Data Management Plans etc
Write test validate and execute software programs to produce SDF datasets
and tables listings and graphs statistical analysis outputs for inclusion within
CSRs ISS ISE IBs INDs publications and other communications
Participate in the finalization of protocol deviations and analysis sets
Approve database freeze
Unblind load and check accuracy of treatment assignment data
Create flash reports or flash memos
Create statistical text for CSRs clinical publications and other communications
Plan and execute statistical review and QC of CSRs clinical publications and
other communications
Assist in planning and contribute to compilation of ISSISEOversee the work of
outsourcing partners and vendors at study level
Create Requests for Proposals RFPs from outsourcing vendors for statistical
services
Contribute to decisions on selection of outsourcing partners
Participate in the development and review of Amgen Policies SOPs and other
controlled documents
Participate in study and systems audits by Amgen CQA and external bodies
and respond to audit questions and findings
Provide input to and participate in intra-departmental and global Biostatistics
meetings
Stay abreast of latest developments in the field of statistics in drug
development and contribute to scientific advances in the field
Promote and communicate statistical awareness and the role of the
Biostatistics department internal & external scientific process
Contribute to the continuous improvement of Global Biostatistics.
Basic Qualifications MS/MSc or PhD equivalent in Statistics or other subject
with high statistical content.

Experience:

Statistical Analysis
Clinical Trials within Pharmaceutical, Biotechnology or Public Health setting in
Industry Government or Academia
Drug Development Pre-clinical Development, Clinical Development, Medical
Affairs
Fundamentals of Project Planning and Management
Communication of statistical information written and oral
International co-operation
Team working

Knowledge :

Statistical Methodology and Applications within Drug Development
Drug Development Process Operations
Use of Biostatistical Software within Drug Development
If you fit the above job description please contact Sue Spice at Datatech on
01256 314 640 or email us on [log in to unmask] Alternatively, Refer a
Friend or Colleague.

Take part in our fantastic referral scheme! If you have a friend or colleague
who would be interested in this role, please refer them to us. For each
relevant candidate that you introduce to us (there is no limit) and we place,
you will be entitled to our generous gift / voucher scheme.

About Datatech Search & Selection:-
Datatech is part of the highly successful `Evergreen Group`, where we
recognise the value in lasting relationships based on shared opportunity and
trust. Our aim is to identify, qualify and deliver talented professionals for our
clients, whilst enhancing the careers of those that we place. For more
information please look at our website or send us a copy of your CV.


For more information for this great opportunity, or to apply, please contact us
at [log in to unmask] OR CALL US ON +44 (0)1256 314 640.

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