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Manager Biostatistics - based Western Europe

Job Field:
CRM (Clinical Research Management) Jobs, IT & Data Management Jobs
Discipline:
CRM Jobs, Clinical Data Coordinator Jobs, Data Management Jobs, Statisticians Jobs
Country:
France, Italy, United Kingdom
Region:
All England
Contract Type:
Permanent
Currency:
Unspecified
Salary Description:
Competitive
Posted:
08-Jun-17
Recruiter:
Quintiles
Job Ref:
1711582

At Quintiles IMS, we know that meaningful results require not only the right approach but also the right people. Regardless of your role, you’ll have the opportunity to play an important part in helping our clients improve patient healthcare. You can drive your career at QuintilesIMS and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information & technology areas, you can seek opportunities to change and grow without boundaries.
Description

ROLE

Manage a team of Biostatistics staff working on a full service partnership.
Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work. Communicate on project progress, staffing, and resource allocation with the Director, Biostatistics, as needed. Perform expert reviews jointly with other Biostatistics management staff. Participate in client meetings. Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports.
Provide training, guidance and mentorship to lower level and new staff

RESPONSIBILITIES

Technical responsibilities:

Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.
Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses.
May participate as a member of a Data and Safety Monitoring Committee.
May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, ISSs, ISEs and/or NDA sections, as required.

Line management responsibilities:

Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
oversee collection and reporting of Biostatistics metrics, implementation of revised work practices, new guidelines, and new software tools as they become available.
Provide training, guidance and mentorship to lower level and new staff


Oversight responsibilities:

Coordinate and participate in process improvements and interoffice/interdepartmental task forces to achieve the partnership goals
Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues.
Make recommendations about resource allocation so as to achieve target utilization rates and project realization rates
Assist in the following: (i) sales meetings as required; (ii) overseeing proposal and budgeting preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions.

Qualifications

Required knowledge, skills and abilities
Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Strong working knowledge of SAS
Excellent written and oral communication skills with good interpersonal skills
Excellent problem solving skills
Excellent presentation skills
Sound judgment/decision making
Ability to lead and motivate a team
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Working knowledge of relevant Data Standards (such as CDISC/ADaM)
Minimum required education and experience
PhD in biostatistics or related field and 5 years relevant experience including 2 years experience managing staff; Master's degree in biostatistics or related field and 7 years relevant experience including 2 years experience managing staff; Bachelor's degree in biostatistics or related field and 10 years relevant experience including 2 years experience managing staff.

Closing Date:
11/07/2017

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