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ALLSTAT  February 2011

ALLSTAT February 2011

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Subject:

*** Hays Pharma - Principal Biostatistician - Global Pharma - US ***

From:

Laura Christie <[log in to unmask]>

Reply-To:

Laura Christie <[log in to unmask]>

Date:

Fri, 25 Feb 2011 16:19:58 +0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (109 lines)

Dear Allstat,

Please find below our latest permanent Stats vacancy:

I have an urgent Principal Biostatistician opportunity to be based in the US office. The ideal candidate will be a very experienced statistician; this must include managing people and projects, and have worked within Neurodegenerative Diseases and MS.

Purpose of the role

*       Function as a project biostatistician coordinating statistical aspects across clinical trials within a specific project in a therapeutic area
*       With limited direction, provide statistical input for statistically complex protocol development.
*       With limited direction, write statistical analysis plans and perform statistical analyses for statistically complex clinical trials
*       With limited direction, write statistical analysis plans and perform statistical analyses for safety and efficacy summaries for regulatory submissions
*       Independently provide statistical input for statistically routine protocol development
*       Independently write statistical analysis plans and perform statistical analyses for statistically routine clinical trials
*       Participate in departmental standardization efforts
*       Provide support towards statistical research

Project Biostatistician Roles and Responsibilities:

*       Participate in clinical development teams
*       Provide statistical input into clinical development plans
*       With limited direction, participate in the development of statistical standards for clinical development programmes
*       Review statistical analysis plans written by other statisticians on the project
*       Review statistical analysis results produced by other statisticians on the project
*       Review statistical methods sections and the interpretation of results written by other statisticians on the project
*       Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation

Functional Roles and Responsibilities:

*       With limited direction, provide statistical input for protocol/CRF development (e.g., trial design; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough evaluation of results section; effective CRF specifications to collect data specified the protocol)
*       With limited direction, write statistical analysis plans for clinical trials as well as for integrated safety and efficacy summaries.  Analysis plans written include the most appropriate statistical methodology and data presentations
*       With limited direction, analyze clinical trials
*       With limited direction, write accurate, logical, clear, concise, thorough and objective statistical methods sections for clinical trial reports
*       Review and co-author clinical trial reports ensuring the accuracy of the statistical interpretation
*       Understand and follow all Global Biostatistics WIs/SOP as well as any other relevant WIs/SOPs.  Provide input into all newly developed departmental quality documents
*       Provide input into general standardization efforts (e.g., CRFs, query checks, statistical methodology, standard statistical programs, data presentations)
*       With direction, interact with regulatory agencies regarding statistical issues
*       With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context
*       Participate effectively on clinical trial teams
*       With direction, provide solutions for complex issues presenting alternatives and identifying the best solution
*       With limited direction, communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused and articulate manner
*       With limited direction, function as the statistical primary contact with CROs for studies that are outsourced, and ensure the accuracy and timeliness of the CROs analysis alerting management to any unforeseen circumstances
*       Produce assigned work within the timelines provided ensuring deadlines are met


Qualifications
*

PhD or MSc in Biostatistics
*       Preferably at least 8 years experience in the Pharmaceutical/Biotechnology industry in clinical development
*       Good SAS knowledge
*       Knowledge of relevant regulatory guidelines applicable to clinical development
*       Familiarization with or ability to develop an understanding of relevant therapeutic areas
*       Excellent project management skills
*       Ideal therapeutic areas - Neurodegenerative Diseases or Multiple Sclerosis.
*       Strong leadership skills, managing projects and people.
*       Regulatory agency interactions experience (FDA, CHMP,)
*       Review and contribute to clinical and statistical sections of regulatory submission dossiers.
*       Participate effectively on clinical development teams and on clinical trial teams.
*       Provide input into statistical timelines and resource forecasts for clinical trials.
For a confidential consultation call Laura Christie on +44 207 633 4825 or email your CV to [log in to unmask]<mailto:[log in to unmask]>

I look forward to hearing from you.

Kind regards,

Laura


Laura Christie
Senior Consultant, Biometrics, Europe
Recruiting experts in Pharma

HAYS Recruiting experts worldwide
25-27 Wootton Street
London
SE1 8TG
T:  +44 207 633 4825
M: +44 7900 932031
F: +44 207 922 7101
E: [log in to unmask]<mailto:[log in to unmask]>

hayspharma.com
------------------------------------------------




******************************************************************************
This message (including any attachments) is confidential and may be legally
privileged. If you are not the intended recipient, you should not disclose,
copy or use any part of it - please delete all copies immediately and notify
the Hays Pharma Helpdesk at [log in to unmask] .

Any information, statements or opinions contained in this message (including
any attachments) are given by the author. They are not given on behalf of
Hays Pharma unless subsequently confirmed by an individual other than the author who
is duly authorised to represent Hays Pharma.

Hays Pharma is a member of the Hays Plc group of companies. Hays Plc is registered in
England and Wales, number 2150950. Registered office, 250 Euston Road, London, England, NW1 2AF.
******************************************************************************

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