Dear Allstat,
Please find below the latest 'Principal Biostatistician' role. You will work
independently on all level complexity clinical trial projects, often with
major regulatory impact. You will be a recognized internally and externally
as a statistical expert.
Responsibilities
* Provide broad statistical support, including trial design,
protocol, and CRF development on specific studies
* Ability to understand regulatory requirements related to specific
therapeutic areas and the implications for statistical processing
and analysis
* Lead production and quality control of randomizations, analysis
plans, statistical reports, statistical sections of integrated
clinical reports and other process supporting documents
* Perform sample size calculations, generate randomization lists and
write statistical methodology sections for inclusion in
study protocols
* Understand and apply extremely advanced and sometimes novel
statistical methods
* Review publications and clinical study reports
* Consult with clients on statistical/regulatory issues
* Provide training in statistical analysis to internal clients
* Interact with regulatory authorities
* Proactively participate in and/or lead process/quality improvement
initiatives
* Perform QC of derived datasets and both simple and advanced tables,
figures and data listings produced by other members of the department
* Provide a supporting role as a non-voting independent statistician
providing data and analysis for DMC review.
* Coordinate and lead a project team to successful completion of a
project within given timelines and budget
* Interact with clients as key contact with regard to statistical and
contractual issues
* Produce derived datasets and both simple and advanced tables,
figures and data listings using efficient programming techniques
* Coordinate development of client proposal documents
* Represent clients marketing and technical meetings
* Check own work in an ongoing way to ensure first-time quality
* Mentor and train other members of the department
* Other duties as assigned
Knowledge, Skills and Traits
* Excellent analytical skills
* Excellent knowledge of statistical analysis procedures
* Good project management skills
* Professional attitude
* Attention to detail
* Thorough understanding of statistical issues in clinical trials
* Prior experience with SAS programming required
* Ability to work independently
* Good mentoring/leadership skills
* Good business awareness/business development skills
Communication
* Address technical issues effectively with written and verbal
communication
* Explain biostatistical and technical issues effectively to
technical and non-technical staff
Education
* Minimum of first degree (undergraduate or equivalent) in
Biostatistics or another relevant discipline
Minimum Work Experience
* At least 6 years experience within the pharmaceutical or other
relevant industry is preferred
I also have a variety of other Biometric specific vacancies available in the
UK and throughout Europe.
Inclusive of SAS programming, Statistical, Data Management functions, please
call me for further details....
If you would to discuss this role in greater detail or your application /
suitability to this or further roles, please call me or email me in
confidence. If you are not available or suited to this position, please feel
free to pass my details on.
For a confidential consultation call Mathew Hogan on 0044 (0) 207 255 6665
or email your CV to [log in to unmask]
Mathew Hogan
Senior Consultant
Pharmaceutical, Biometrics & CRO Division
1st Pharma People
A Division of 1st-IT People
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
mailto:[log in to unmask]
<mailto:[log in to unmask]>
www.1st-pharmapeople.com <http://www.1st-pharmapeople.com/>
PLEASE NOTE: As of 31st May 2005 our office address will change to; 1st IT
People, 3rd Floor, Woolverstone House, 61-62 Berners Street, London. W1T
3NJ. As a result of this, we do have a new telephone number of 0207 255
6665. Please note our previous phone number will still work.
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