Dear Allstat,
 
Please find the latest PERMANENT Biostatistics vacancy.
 
The Role
Oversees statistical aspects of  multiple clinical development programs and
internal systems, serves as internal statistical consultant for multiple
areas. 

 

Plans specialized clinical trials to establish product's superiority over
other currently available products, or development areas new to the
industry. 

 

Publishes technical reports and presents at external scientific meetings,
serves as co-author on company-sponsored publications involving clinical
trials. 

 

Represents the company in regulatory discussions involving nonstandard
statistical techniques for the assigned programs.

 

Accountabilities

 

¨       Leads statisticians for multiple programs.

¨       Contributes to the resolution of nonstandard statistical technical
issues. 

¨       Serves as statistical expert on problems associated with a
particular design or analysis. 

¨       Primary contact and prime spokesperson for communications with other
parties for the assigned programs

¨     Communicates with regulatory agencies regarding complicated
statistical issues for the assigned programs

 
Desired Knowledge
 
¨   Broad clinical trial design knowledge as applied to multiple classes of
drugs and different phases.

¨   Knowledge of simulation techniques to provide informed opinions on drug
development. 

¨   Expert level knowledge of statistical software and broad knowledge of
other advanced software products, programming languages, and technologies
necessary to perform very complex statistical analyses and design internal
systems. 

 ¨    In depth knowledge of multiple clinical areas and related disciplines
such as Pharmacokinetics.

 
 

Functional/Technical


¨       Ability to design complicated clinical development plans in
diversified therapeutic areas.

¨       Ability to deign or perform complicated statistical analyses in
broad statistical technical areas.

¨       Assists in assessment of the impact of study designs and clinical
development plans on the development of compounds and strategic development
of the company business.

¨       Ability to author and review statistical sections of IAE and IAS of
NDA and other submissions. 

¨       Ability to define cross-function task forces to support global
regulatory submissions.

¨       Forward thinker with broad background of problem identification and
resolution. 

¨     Knowledge of major activities involved with regulatory submissions and
ability to interface well with other clinical scientists to ensure smooth
incorporation of novel statistical techniques in submissions.
 
Approach
¨       Projects, defines and clarifies emerging needs of product teams and
strategic teams and aligns Stats group's activities to meet these needs.

¨       Develops and communicates plans and processes that deliver solutions
of value to product teams and strategic teams beyond expectations

¨     Ensures Stats group activities performed for business partners provide
value and manages business partner expectations accordingly
 

Working Relationships


¨       Outlines the direction, facilitates effective interactions, and
generates excitement for the Stats group to excel

¨       Leverages the experience and knowledge found in the Stats group,
product teams and strategic teams when developing team and project plans.

 

Managing Change

¨       Identifies and communicates opportunities provided by changes in
business environment and translates strategic changes into workable plans
for the team to meet changing business needs.

¨       Prepares the team to effectively respond to and adapt to change.

¨     Act as a role model and motivates others to make changes that improve
the way things are done, allowing freedom for failure.
 

 


Results Orientation


¨       Develops plans and processes for Stats group to achieve priority
initiatives in a time sensitive manner.

¨       Communicates results expectations to group members and holds
individuals and the group accountable for achieving results.

 

Leadership


¨       Communicates, leads by example and motivates others to demonstrate
behaviors that support team and company goals.

¨       Initiates feedback process and seizes coaching opportunities to
develop, train and motivate others.

¨     Identifies, promotes and tracks learning opportunities for group
members, while continuously pursuing self-development and growth.
 
 
Education and Experience
¨     PhD in Statistics or Biostatistics with 8+ years of experience
supporting clinical trials in the                     pharmaceutical
industry; 

¨     MS in Statistics or Biostatistics with 10+ years of experience.
 
 

Physical Demands

 

¨       Ability to drive to or fly to various meetings/sites - may include
overnight stays.  

 

¨     International travel may be required.

 

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 mathew.hogan <mailto:[log in to unmask]>
@1st-pharmapeople.com

 

 
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]
 <http://www.1st-pharmapeople.com/> 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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This email is confidential and intended solely for the use of the 
individual to whom it is addressed. Any views or opinions presented are 
solely those of the author and do not represent those of the company from 
which the email was sent. If you are not the intended recipient, be advised 
that you have received this e-mail in error and that any use, dissemination 
forwarding, printing or copying of this e-mail is strictly prohibited. 
While every effort has been made to scan this e-mail, we can not accept any 
responsibility for loss of business or damage caused arising from this
e-mail.