Dear Allstat,
The Role - Lead Statistician
To be the lead statistician on a number of projects on a compound across all
phases of clinical trials providing clear well thought through statistical
input that is meaningful and that adds value in a timely and effective way.
Key responsibilities
* Help develop the Clinical Development Plan and The Development Plan
for all allocated projects by ensuring that the required number of patients
and study designs are scoped for the most effective outcomes for each
programme taking into consideration the specific needs of each one.
* Proactively develops protocols by establishing; power
calculations/study design, statistical methods, general review and
discussion review of protocol amendments.
* Write statistical analysis plans for CRO's to use that are clear
and are not open to misinterpretation in addition to reviewing the
statistical analysis plans written by CRO's ensuring that they are complete
and meet our needs.
* Liaise with CRO's on randomisation schemers.
* Review tables, listings and figures produced by CRO's to check for
accuracy following through any issues identified to conclusion.
* Review and input into Clinical study reports, ensuring that the
content of the report makes good statistical sense.
* Development of ISS/ISE documents
* Communication and liaison with Regulatory authorities in Europe and
the US (predominantly) as required.
* Provide any ad hoc analysis as requested by either the Development
or Research team in a timely way.
* Provide support as required to the marketing and commercialisation
of compounds by inputting to publication and symposiums.
* Contribute to process improvement , new systems and methods.
You will be:
Qualifications:
* First degree in statistics or mathematics.
* Post graduate qualification in statistics, preferably medical
statistics.
* Possibly a Chartered Statistician.
Knowledge:
* Must have a working knowledge of protocol development, statistical
analysis plan writing and carrying out analysis and reporting in a
CRO/Pharmaceutical environment.
* Clinical Trial methodology
* Understanding of the MHRA and FDA and have already worked in
partnership with them and has started to build relationships in these areas.
* Has previously lead or has significantly contributed to a number of
NDA and MLA.
Skills:
* Excellent communication skills, providing both written and verbal
communication in the most effective way for the targeted audience.
* Has the capability to influence people who may be internal or
external, senior or a peer across the Development spectrum
* Listens to others views and takes on board their views and
opinions, incorporating them into their thinking where appropriate.
* Has the capability to lead others, inspiring confidence and working
with people in an open and transparent manner encouraging all team members
to reach their potential in everything that they do.
* Has an understanding of how to effectively engage with CRO's and is
able to spot what are the critical issues and focus on those bringing them
to a successful conclusion, not getting distracted by lower priority items.
* Understand statistics in the Clinical area to a high level having
observed different ways of completing the necessary requirements and now has
a view of how best to achieve these in the most effective and efficient way
for a medium sized organisation who operate a virtual Development group.
* Is able to prioritise and multi- task effectively.
* Can sensitively and flexibly work globally where required.
If you would like to discuss this role in greater detail or your application
/ suitability to this or further roles, please call me or e-mail 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.
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.
|