Job Description
POSITION DESCRIPTON
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.
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