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ALLSTAT  November 2009

ALLSTAT November 2009

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Subject:

BIOSTATISTICIAN

From:

Lauren Jones <[log in to unmask]>

Reply-To:

Lauren Jones <[log in to unmask]>

Date:

Thu, 26 Nov 2009 11:57:26 +0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (93 lines)

Dear All, 

'DATATECH PHARMACEUTICAL' have the following position....

BIOSTATISTICIAN
BASED IN - UK

We currently have an opportunity for an experienced Biostatistician to join the 
Oncology Therapeutic Area, initially on an 11 month contract within 
International R&D.

You will be responsible for 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 and adhering to all Policies, SOPs and other controlled 
documents.

Key responsibilities:
-To co-ordinate the design, statistical analysis and reporting of individual 
studies
-To represent Biostatistics on study teams 
-To provide statistical input for publications, presentations and in-house 
decision-making

Function as a Study Statistician with the following key activities:
-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 (e.g. 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 ISS/ISE
-Oversee 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 Policies, SOPs and other 
controlled documents
-Participate in study and systems audits by 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

You will need as a minimum an MS/MSc or PhD/equivalent in Statistics or other 
subject with high statistical content and will have demonstrable experience 
within clinical research of the folllowing:-
-Statistical Analysis
-Clinical Trials within Pharmaceutical/Biotechnology/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


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.


FOR MORE DETAILS ON THIS GREAT OPPORTUNITY, PLEASE SEND US YOUR CV 
TO - [log in to unmask] OR CALL US ON +44 1256 314 640.

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