JiscMail Logo
Email discussion lists for the UK Education and Research communities

Help for ALLSTAT Archives


ALLSTAT Archives

ALLSTAT Archives


allstat@jiscmail.ac.uk


View:

Message:

[

First

|

Previous

|

Next

|

Last

]

By Topic:

[

First

|

Previous

|

Next

|

Last

]

By Author:

[

First

|

Previous

|

Next

|

Last

]

Font:

Proportional Font

LISTSERV Archives

LISTSERV Archives

ALLSTAT Home

ALLSTAT Home

ALLSTAT  February 2007

ALLSTAT February 2007

Options

Subscribe or Unsubscribe

Subscribe or Unsubscribe

Log In

Log In

Get Password

Get Password

Subject:

Principal Statistician - London Based - Permanent Vacancy - Excel lent Opportunity

From:

Nicole Gunn <[log in to unmask]>

Reply-To:

Nicole Gunn <[log in to unmask]>

Date:

Wed, 21 Feb 2007 12:29:12 -0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (110 lines)

JOB SUMMARY:
Working for a Top 15 Pharmaceuticals Company, the fastest growing in their
field; A company that take care to provide better health for individuals and
strive to create a scientific progress in medicine by developing safe,
effective and innovative pharmaceutical products.
Located in London, this is an opportunity to work with a company that rarely
recruits externally and takes real pride in it's employee's achievements,
this is and excellent opportunity to take the next step in your career.

OBJECTIVE
The purpose of this position is to provide program/therapeutic
area/development phase statistical expertise and leadership by:
∑         Designing, analyzing and interpreting clinical studies and
programs (US and EU).
∑         Providing strategic statistical input for feasibility assessments,
development plans, cross-study analyses and regulatory submissions.
∑         Standardizing study design, analysis methodology and presentations
to maximize global data integratability and inter-program efficiency.
∑         Leveraging external vendors providing statistical services to
achieve quality, timely, cost-effective study deliverables.
∑         Independently representing Statistics function in interactions
with regulatory authorities.

DUTIES AND RESPONSIBILITIES
∑            Represent the statistics function on global teams in support of
clinical studies and programs led from either the US or EU.
∑            Provide strategic statistical input to feasibility assessments,
development and submission plans, and defence of regulatory submissions. 
∑            Provide accurate, statistically appropriate outputs included in
protocols, statistical analysis plans, study reports and regulatory
submission documents.
∑            Oversee definition and implementation of project level database
(including derived database), analysis and reporting standards.  
∑            Plan and direct program-level analysis and reporting activities
including work of other statisticians and programmers.
∑            Identify program-level vendor requirements and participate in
the evaluation/selection of BDM vendors. Provide technical oversight of
statistical activities of external vendors to ensure timeliness and quality
of analysis data and statistical outputs. Review and approve key statistical
vendor deliverables.
∑            Identify and interact with external statistical experts for
issues related to design, methodology and results.
∑            Anticipate and communicate resource and quality issues that may
impact deliverables or timelines.  Propose and implement solutions. Escalate
issues to management as appropriate.
∑            Increase efficiency of the Statistics function through
development of standard analysis methodology, data presentations and sharing
of best practices. Lead the implementation of such standards and process
improvements.
∑            Monitor and contribute to industry advances in statistical
methods to optimize study designs and statistical analyses.
∑            Comply with all applicable regulatory requirements, standards
and procedures.
∑            Perform other duties as assigned

QUALIFICATIONS:
∑            MS in statistics or biostatistics and 10 years of relevant
pharmaceutical industry experience, or PhD in statistics or biostatistics
with minimum of 7 years of relevant pharmaceutical industry experience. 
∑            Experience on at least two global projects and at least two
NDA/CTDs.
∑            Advanced knowledge of clinical study designs, common analysis
methods, descriptive and inferential statistics, and data presentation
practices.
∑            Advanced knowledge of the pharmaceutical industry including
understanding of clinical drug development process and documents. 
∑            Knowledge of FDA and ICH regulations and industry standards
applicable to the design and analysis of clinical trials.
∑            Demonstrated success independently representing Statistics
function in interactions with FDA including end of Phase II, pre-NDA
meetings or advisory committee meetings.
∑            Good knowledge of statistical programming languages (including
SAS), software, techniques, and processes. Working knowledge of UNIX
operating systems, and common software products and technologies used in
conjunction with SAS (e.g., Microsoft Office“ products).

 

 
Nicole Gunn
Biometrics Consultant
Pharmaceutical, Healthcare & 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/> 
 
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 the loss of business or damage caused arising from this
email.
 
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. 

Top of Message | Previous Page | Permalink

JiscMail Tools


RSS Feeds and Sharing


Advanced Options


Archives

November 2017
October 2017
September 2017
August 2017
July 2017
June 2017
May 2017
April 2017
March 2017
February 2017
January 2017
December 2016
November 2016
October 2016
September 2016
August 2016
July 2016
June 2016
May 2016
April 2016
March 2016
February 2016
January 2016
December 2015
November 2015
October 2015
September 2015
August 2015
July 2015
June 2015
May 2015
April 2015
March 2015
February 2015
January 2015
December 2014
November 2014
October 2014
September 2014
August 2014
July 2014
June 2014
May 2014
April 2014
March 2014
February 2014
January 2014
December 2013
November 2013
October 2013
September 2013
August 2013
July 2013
June 2013
May 2013
April 2013
March 2013
February 2013
January 2013
December 2012
November 2012
October 2012
September 2012
August 2012
July 2012
June 2012
May 2012
April 2012
March 2012
February 2012
January 2012
December 2011
November 2011
October 2011
September 2011
August 2011
July 2011
June 2011
May 2011
April 2011
March 2011
February 2011
January 2011
December 2010
November 2010
October 2010
September 2010
August 2010
July 2010
June 2010
May 2010
April 2010
March 2010
February 2010
January 2010
December 2009
November 2009
October 2009
September 2009
August 2009
July 2009
June 2009
May 2009
April 2009
March 2009
February 2009
January 2009
December 2008
November 2008
October 2008
September 2008
August 2008
July 2008
June 2008
May 2008
April 2008
March 2008
February 2008
January 2008
December 2007
November 2007
October 2007
September 2007
August 2007
July 2007
June 2007
May 2007
April 2007
March 2007
February 2007
January 2007
2006
2005
2004
2003
2002
2001
2000
1999
1998


WWW.JISCMAIL.AC.UK

Secured by F-Secure Anti-Virus CataList Email List Search Powered by the LISTSERV Email List Manager