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ALLSTAT  August 2008

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Subject:

Senior Biostatistician with innovative global Biotech in San Francisco

From:

Fforde Management <[log in to unmask]>

Reply-To:

Fforde Management <[log in to unmask]>

Date:

Mon, 18 Aug 2008 15:50:40 +0100

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (63 lines)

Senior Biostatistician
Ref: 00352

This is an outstanding opportunity for an experienced Biostatistician to work 
for the company that is known as the founder of the biotech industry, and 
uses human genetic information to discover, develop, manufacture and market 
biotherapeutical products that address unmet medical needs.  They have 
multiple products on the market and a strong pipeline of projects that 
guarantee long term growth.  They Require a Senior Biostatistician at their 
office in San Francisco.

JOB ROLE:  The Senior Biostatistician works with senior biostatistics staff and 
clinical monitors on clinical development plans; the design and conduct of 
clinical studies; the evaluation, interpretation, and reporting of study results; 
and regulatory submissions to the FDA.

PRINCIPAL RESPONSIBILITIES include:   
•	As part of a development assessment team, collaborating in the 
preparation and review of the clinical development plan. 
•	Providing statistically sound experimental design and data analysis 
input to meet project objectives and FDA statistical requirements for assigned 
clinical development projects. 
•	Reviewing all project protocols, authoring protocol statistical 
analysis sections, and generating study randomization. 
•	Reviewing case report forms to ensure that protocol objectives 
are met and project standards are maintained. 
•	Developing study analysis plans and leading this effort for selected 
studies. 
•	Developing statistical programs as necessary to perform analyses 
and prepare data displays. 
•	Authoring results sections of the clinical study report. 
•	Supplying statistical input for BLA submissions and in response to 
FDA questions. 
•	Providing support for publication of clinical trial results. 
•	Keeping abreast of new developments in statistics, drug 
development, and regulatory guidance through literature review and 
attendance at workshops and professional meetings.

QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
•	PhD in Statistics/Biostatistics with at least 2 years of clinical trials 
experience. 
•	Experience with statistical software packages such as SAS and S-
Plus. 
•	Sound knowledge of theoretical and applied statistics. 
•	Sound understanding of regulatory guidelines in a pharmaceutical 
research setting. 
•	Effective skills in communication and team collaboration.

BENEFITS OF THE ROLE:  This Company has been nominated by two well 
known publications for years in succession as a top employer in the 
biopharmaceutical industry and one of the best companies to work for.  They 
are aware that their employees are critical to business success and are 
committed to providing a great work environment with programs, services and 
benefits that offer great career development opportunities and enhance their 
employees’ personal lives.  

Fforde is a uniquely specialised recruitment agency/business for the 
pharmaceutical, clinical research and biotechnology sectors.  For applications 
please email your CV to: [log in to unmask] or speak to our 
specialist consultant, Nando Rodriguez on +1 212 520 8323 who will be 
pleased to give you further information and advice on your personal career 
needs.  Visit our website and see all our job opportunities at www.fforde-
management.com

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