Biostatistics Opportunities, Chicago, CRO

[James L Rosenberger <JLR@stat.psu.edu>]

Hello, 
 
I am a recruiter with Alchemy Scientific, Inc., we specialize in
recruiting professionals for the pharmaceutical/biotech industry and can
be found at
www.alchemyscientific.com
.
 
Currently we have the following opportunities in Biostatistics for the
Chicago office of a prominent national CRO.  Our client has 30 sites
with over 400 clinical research professionals. 
 
Director ? Biostatistics & Programming
 
Biostatistician, Data Management
 
The salaries are very competitive plus bonus and benefits.
 
 
Would you know of anyone who might be interested?
 
 
 
The opportunity descriptions are as follows:
 
Director ? Biostatistics & Programming
The Director of Biostatistics and Programming will lead project
team(s) in the areas of experimental design, protocol development,
statistical analysis plans and statistical analysis to meet project
objectives and development of statistical section of clinical study
reports, INDs, NDAs, and annual reports.
 
Other duties will include:

• Serve as a biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to Phase I-IV clinical trials

• Represent clients at FDA meetings, FDA advisory boards, or other scientific meetings as required

• Direct statistical and programming support activities, including allocation of resources, overseeing the scheduling of projects, and monitoring the project status.

• Evaluate the statistical and programming deliverables generated by supervised staff for validity and quality

• Ensure compliance with, and participate in development of departmental SOP's

• Lead in and contribute to the establishment and maintenance of common formats and templates for key Biostatistics and Programming documentation (eg statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings).

Required Skills:

• Knowledgeable concerning the FDA, International Regulatory Agencies, and ICH guidelines and regulations applicable for the conduct, analysis and reporting of clinical trials and data systems
• Knowledgeable in current statistical theory and methods as applied to clinical trials 
• Ability to communicate complex issues in verbal and written form
• Proficient in SAS and nQuery Advisor software packages

Education:

• Ph.D. in biostatistics or closely related field with 3 years of relevant experience, or M.S in biostatistics or closely related field with 6 years of relevant experience

Biostatistician, Data Management 
The Biostatistician will work with the project team to form
analysis plans, analyze studies, and produce tables and listings for
study results.  The Biostatistician will provide statistical support
to the project team and sponsor by presenting and interpreting
statistical results.  Other duties include:

• Reviewing and approving case report forms.
• Assisting with data preparation plan.
• Preparing statistical analysis plans based on the study protocol.
• Assuring the analyses are properly conducted and reported. 
• Reviewing the work of programmers to ensure quality of statistical results.
• Providing guidance to the project team in the verification and documentation of studies.
• Reviewing final reports to assure statistical results and conclusions are correct.

The successful candidate must be able to clearly communicate the
statistical issues/results to the project team, sponsor, or investigator
in both written and verbal form; to speak and present effectively in
formal and informal settings; and to meet study timeline goals. 
 
Candidate requirements:

• Bachelor?s degree in statistics with additional experience; Master?s degree preferred.
• Two years? industry experience, analyzing and interpreting data from clinical studies.
• Excellent communication skills, both written and oral. 
• Adaptable to changes in work duties, responsibilities, and requirements.
• Detail-orientated, thorough and methodical, and able to do long-range planning and to create and follow timelines. 

Our client provides a site with staff that exhibits team spirit and a
genuine sense of pride in conducting research. There is a competitive
salary and benefits offered with this position as well as the opportunity
for growth.
 
 
 
If you know of anyone who might be interested, any suggestions are
greatly appreciated.  Also, all interested candidates are welcome to
contact us and send their resume as a Word file.
 
All inquiries are kept strictly confidential.
 
Thank you,
 
 
Steven Karski
Alchemy Scientific, Inc.
51 JFK Parkway, First Floor West
Short Hills, NJ 07078
 
973-218-2600
skarski@alchemyscientific.com