You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Vacancy details
Vacancy description:
Job Code:
00312
Job Title:
Biometrics Manager
Job Category:
IT & Data Management
Contract:
Permanent
Discipline:
Statisticians, Data Management, Director
Country:
United States Of America
Location:
Massachusetts
Min experience:
5 years
Annual salary:
Negotiable
Apply by:
04 Jun 2008
This is an excellent opening for an experienced Biostatistician to take a management role with a prominent global CRO that serves the pharmaceutical, biotechnology and medical device industries. The company's services ranging from full clinical trials management services throughout the clinical trials lifecycle right through to FDA and product registration support. They require a Biometrics Manager at their office in Southborough, MA.
JOB ROLE: The Biometrics Manager manages a group of analysts and statisticians providing project leadership and personnel mentoring. With minimal oversight he/she manages Biostatistics resources and activities, including coordination within the group and with SAS programmers, and interaction with internal and external clients, to ensure successful completion of projects. The position is also responsible for assisting the Senior Director in departmental training, process standardizing/improving, and achievement of departmental and corporate goals.
PRINCIPAL RESPONSIBILITIES include:
�Directing the creation of analysis plans, derived datasets and tables/listings/figures (TFL) programming specifications.
�Overseeing the productions of TFL, the quality review processes, and the archiving process for all projects to ensure compliance with SOPs, quality of derived datasets and TFL, and timely completion.
�Managing personnel activities ensuring company processes are adhered to and performance evaluations.
�Coordinating resource distribution across projects
�Assisting the Senior Director to:
oDevelop and maintain Biometrics SOPs and working instructions
oDevelop budget proposals
oProvide percent-complete and estimated-time-to-completion of analysis components to the central resource tracking facility
oResolve operational issues
�Representing clients at FDA or other regulatory authorities meetings
�Functioning as a senior reviewer or serve as a lead Biostatistician on selected projects
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
�PhD or Masters in Biostatistics or closely related fields
�5�8 years experience in drug/biologic/device development in pharmaceutical, biotechnology or device industry
�Thorough knowledge of statistical principles, experimental design, and data analysis in clinical trials
�Experience in SAS and other statistical software
�Experience interacting with FDA or other regulatory authorities, and familiar with guidelines of regulatory authorities
�Experience leading diverse teams simultaneously
PERSONAL SKILLS & ATTRIBUTES:
�Excellent communication, interpersonal and presentation skills.
�Excellent organizational skills
BENEFITS OF THE ROLE: There are fantastic career opportunities available with this prominent, global CRO for positions in the clinical development process. The company is an equal opportunities employer, offering competitive salaries and a range of excellent benefits including: paid vacation/holiday time off, health, dental and life insurances, 401(k) retirement saving and profit sharing plan, tuition reimbursement and a flex-time policy.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors.
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Site by Redder