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POSITION DESCRIPTION

A PREEMINENT CRO LOCATED ON THE EAST COAST OF THE U.S.


TITLE:                       Biostatistician

REPORTS TO:            Head, Biometrics

THE COMPANY

This preeminent CRO with over 120 employees provides a broad range of 
project management, data management, medical oversight, and statistical 
design and analysis services primarily to leading university investigators 
as well as the pharmaceutical and medical device industry.

THE FUNCTION

This biostatistician will provide biostatistical expertise and project 
involvement for multiple projects.


RESPONSIBILITIES

·        Serve as contact with sponsors for statistical aspects of assigned 
projects
·        Monitor timelines and resources for assigned projects
·        Prepare statistical sections of protocols including sample size 
calculations
·        Review protocols and CRFs for assigned projects
·        Oversee and/or prepare detailed statistical analysis plans
·        Oversee and/or conduct statistical analyses on assigned projects
·        Oversee and/or perform validation and quality control of data 
displays that show inferential statistics
·        Review and/or write statistical documents generated in support of 
assigned studies
·        Review integrated clinical/statistical reports to ensure adequate 
presentation of statistical methodology and interpretation of results.
Additionally this person will:
·        Participate in FDA teleconferences/meetings as required
·        Participate in business development meetings/presentations.
·        Handle miscellaneous tasks as assigned by management.

REQUIRED EXPERIENCE

·        A minimum of three to six years of experience in an appropriate 
industrial, academic, or consulting organization. CRO, pharma, biopharm or 
medical device experience preferred.

·        Must have advanced computer skills as well as leadership, decision 
making, and strong communication abilities.

·        Experience of simultaneously handling multiple projects and 
occasionally stressful situations.

·        Ideally, will have demonstrated experience in the clinical 
research process, trial design, development of protocols/analysis plans, 
database management, and FDA/EMEA regulations and guidelines.

·        Must have a strong working knowledge of statistical clinical trial 
methodologies as well as electronic data capture/collection and DB 
structures and familiarity with coding dictionaries (WHO, COSTART, ICD-9, 
MedDRA).

·        Thorough working knowledge and experience with the clinical trial 
and drug development process and the role the CRO plans in that process.

·        Experience with SAS programming and knowledge of regulatory 
requirements is required.


EDUCATION

A Ph.D. with 3 to 5 years in biostatistics is preferred, but an M.S. with 4 
to 6 years experience may suffice.


QUALIFICATIONS and PERSONAL ATTRIBUTES

·        Must have the presence and interpersonal skills to win credibility 
with colleagues within the academic and pharmaceutical community.

·        Must have the ability to discuss and present the statistical 
aspects of studies with investigators, medical directors, management, and 
regulatory authorities.

·        Ability to interact comfortably and effectively with members of 
other departments, including both management and non-technical staff.

·        Must reside, or be willing to relocate, to the greater Boston area.




Please respond by email, not by phone.

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Paul E. Came
Managing Partner
Came|Sweeney
1033 Skokie Blvd., Suite 370
Northbrook, Illinois 60062