Dear Allstat,

Please find below the details of our latest contract position in the UK.
This is a 12 month extendable contract role for a Senior Statistician
based in the M4 corridor area.

Position Summary	
Responsible for providing statistical support as assigned by the
Manager.  May serve as primary biostatistician on one or more projects.
Participates in the development of study protocols including
participation in study design discussions. Reviews CRFs and data edits.
Develops statistical analysis plans including analysis file and report
specifications.  Performs statistical analyses, interprets statistical
results, and prepares clinical study reports including integrated
summaries for submissions.
	
Principal Duties and Responsibilities
Essential Functions:
*	Participate in protocol development ensuring that the design
meets the objectives and is optimal within the imposed constraints.
Perform sample size estimates and/or power calculations to evaluate the
costs of various design scenarios.  Review CRFs and data edits. Perform
sample size estimates and/or power calculations.   Propose methods for
statistical analysis and prepares statistical section of protocols.
*	Prepare randomization schedule.
*	Prepare statistical analysis plans (including specifications for
analysis files and report tables), perform the analyses of the clinical
data, and adherence to project conventions.  Is able to analyze complex
data issues and readjust analysis plans according to statistical
considerations.
*	Lead study team in the review and discussion of analysis plan,
report plan, and results.
*	Understand and utilizes those aspects of computer science
necessary for efficient data management and statistical analysis.
Propose and review procedures relating to computer usage.  Conduct
complex statistical analysis utilizing SAS* and other statistical
software packages, as required.
*	Interpret statistical results and presents findings in an
appropriate format.  Prepare the statistical methods and results
sections of clinical study reports ensuring that graphical and tabular
summaries are clear and concise and that the objectives of the study are
addressed.  May present statistical results to non-statisticians for
clinical interpretation.
*	Maintain project files ensuring adequate, clear documentation of
data sources, management and analysis.

Additional Functions:
*	Provide general consultation and training to appropriate Company
personnel, usually on an informal, as-needed basis.
*	Maintain proficiency in statistics and regulatory issues through
training courses, participation in appropriate societies, review of
professional literature, industry and academic contacts, etc.	

Job Demands	
*	Demonstrate excellent leadership and communication skills.
*	Possess knowledge of regulations and follow appropriately.
*	Ability to work independently on routine assignments, under
supervision on new assignments.
*	Ability to identify and resolve areas of concerns.  Work with
others as necessary.
*	Ability to maintain confidentiality.
*	Demonstrate strong organizational skills, including the ability
to prioritize workload.

Qualifications 
Essential:
*	MS or PhD in Biostatistics/Statistics or equivalent.
*	Varied and extensive experience working on clinical trials.

Preferred:
*	IND/BLA/NDA/MAA experience desired but not essential.

Technical Skills:
*	Thorough understanding of statistical principles and clinical
trial methodology with the ability to practice and implement them.
Ability to provide solutions to a variety of technical problems of
moderate scope and complexity.
*	Some knowledge of medical/biological terminology and clinical
trial designs in relevant therapeutic areas.
*	Attentive to detail.
*	Excellent written and oral communication skills including
grammatical/technical writing skills.
*	Conversant with SAS programming, and knowledge of SAS procedures
and other statistical software.
*	Working knowledge of regulatory guidelines relating to
statistical analysis, study reports and statistical components of
regulatory submissions.

Interpersonal Skills:
*	Effective communicator: able to explain methodology and
consequences of decisions in lay terms.
*	Effective team player; willingness to go the extra distance to
get results, meet deadlines, etc.
*	Able to be flexible when priorities change.  Able to deal with
ambiguity.

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: http://www.jamesharvard.com/pharma/careers_browse.htm.

I look forward to hearing from you.

Kind Regards,

Chris Smith
Consultant ~ Biostatistics Division
James Harvard Pharmaceutical Ltd

T. +44 (0)20 7922 7137   M. +44 (0)7919 448334     F. +44 (0)20 7922
7101
E: [log in to unmask]    
W: www.jamesharvardpharma.com

25 - 27 Wootton Street : Waterloo : London : SE1 8TG

For the latest Statistics and SAS Programming vacancies go to
http://www.jamesharvard.com/pharma/careers_browse.php

 

______________________________________________________________________
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email 
______________________________________________________________________