MASTER’S NOTEBOOK
Solve Problems in the Pharmaceutical Industry
with Contract Research Organizations
O
ver the last several years, many industries (including the
Mani Lakshminarayanan, Committee on Applied Statisticians
pharmaceutical industry) have implemented cost-saving
measures, including downsizing their work forces and
concentrating on their core skills. While retaining their basic sci-
entific and operational talent for innovation and excellence, these null
Statisticians at these organizations
industries have begun collaborating with contract research organi-
experience rewarding consulting encoun-
zations (CROs) to develop processes and solve problems.
ters with a variety of clients working on a
A CRO is an independent entity that consists of contractors
and typically offers services to pharmaceutical and biotech indus-
plethora of statistical problems.
tries. Their services include all aspects of drug development and null
the conduct and reporting of clinical trials. Above all, CROs can
organizations experience rewarding consulting encounters with
provide the following:
a variety of clients working on a plethora of statistical problems.
The demand and nature of projects typically prevalent in CROs
require candidates with a master’s degree for the positions of proj-
ect statistician or statistical programmer.
As in the pharmaceutical industry, statisticians in CROs work
on the following aspects of drug/medical devices development:
Statistical aspects of study design
Protocol input
Design and sample size issues
Development of statistical analysis plans
Development and evaluation of methodology
Data analysis
Full continuum of R&D needs so industry can
accomplish a broad range of therapeutic expertise
Statistical tables, graphs, and listings
Support for conducting trials in geographically Statistical reporting
dispersed areas
Statistical report writing
Full range of services to customers who wish to go with
their preferred providers
Reporting of integrated safety and efficacy summaries
Flexibility of global filing of registration packages Creation of integrated databases
Reduction in time developing pharmaceutical products while Besides these core statistical consulting problems, statisticians
continuing to meet patients’ needs is the winning combination have the opportunity to explore information technology–related
for any successful pharmaceutical company. As strategic partners
issues, such as integrated information processing (safety/efficacy
in drug development, CROs are a cost-effective option.
summaries), real-time information sharing (electronic data cap-
Many pharmaceutical companies, as part of their strategic ini-
ture), and global data harmonization. As most pharmaceutical
tiatives, are leveraging the external capabilities of CROs, especially
companies are global, they need to leverage clinical and technical
in routine tasks. As a result of the acute and long-term need, there
expertise to accomplish simultaneous global filing on a timely
has been an explosion of CROs in number and capability. Many
basis. Involvement with global filing also provides unique experi-
ences in understanding and conducting clinical trials in emerging
are able to provide consulting or full drug-development services.
global markets, such as India, China, and Latin America.
For statisticians, this aspect is translated into a multitude of
Career opportunities for statisticians have always been con-
opportunities for designing and reporting small and large clinical
sistent, and in the current environment of globalization, career
trials, which can span all therapeutic areas and long- or short-
choices are numerous in both pharmaceutical companies and
term phases. Occasionally, statisticians get involved with several
CROs. The value of contracts given to CROs is expected to
projects at the same time with both short- and long-term dead-
reach almost $20 billion by 2010. This enormous figure should
lines. Working in a CRO, statisticians can get more experience
be good news to all statisticians seeking challenging and reward-
working on a variety of projects. Above all, statisticians at these
ing employment opportunities. n
JUNE 2008 AMSTAT NEWS 25
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