Biostatistician

gree / College Major: Masters or PhD statistician

Primary Job Responsibilities and Qualifications:

The candidate should have a Masters or, preferably, a PhD in Statistics.  The immediate requirements are to be the lead statistician on a large, multi-center outcomes clinical trial. The candidate will contribute to the design and writing of the protocol.  This will require independent review of relevant literature.  It is expected that the candidate will propose design improvements that will meet clinical and commercial requirements.  Developing the study design typically requires developing many scenarios, which require simulations.  Knowledge of methods of survival analysis, interim analysis and multiplicity is required.

As the protocol is being developed, there will be Advisory Boards with external research groups and Key Opinion Leaders.  The candidate would need to be a senior individual that the project team had full confidence in, in order to attend these kinds of meetings.  There would likely be an FDA meeting to discuss the protocol, so regulatory experience is desirable.

After the study is launched, a Statistical Analysis Plan will need to be developed.  The person should be capable of developing detailed analysis plans for primary, secondary and backup analyses.  There will also be work with Statistical Programmers developing table templates.

The candidate should be able to do hands-on SAS programming, but there should be some part-time support from a lower level statistician and statistical programmer.

Supervisory experience would be helpful.

There should be the ability to initiate ongoing review of blinded data as the study develops, to help with ensuring data quality, anticipate issues with trial conduct, and help predict the end of the study.

The candidate should be able to participate in defining the Data Monitoring Committee charter and should be able to represent the study at Executive Committee meetings.
As the database cutoff approached, the candidate will organize and run a blinded data review of tables.  There will be a great deal of involvement in the analysis and reporting of the study.  Typically, there are several internal meetings with senior management.  The candidate may be asked to participate in these meetings, depending upon the issues. The candidate will participate in writing the study report and with analysis and writing of manuscripts.

Category:	Biotech/Pharmaceutical
Location:	Wilmington, DE
County:	New Castle County
ZIP Code:	19801
Pay Rate:	Negotiable
Job Terms:	7-12 months (contract)
Company:	PSCI
Phone:	1302-334-4107
Fax:	email only