Associate Director Biostatistics Home Or Office Based Nationwide

Quintiles Transnational Corporation

PURPOSE

Manage a team of Biostatistics staff. May fulfill the role of site head or functional head within a site. Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work. Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials. Assist the Director in strategic planning and resource allocation for the department. 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. Assist the Director in proposal development, FTE allocation, budget projections, and client presentation, as needed. Conduct independent research and teaches courses in statistical methodology as resources permit.

 

RESPONSIBILITIES

 Technical responsibilities:

 

i) Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.

ii) Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses.

iii) Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee.

iv) As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication.

v) 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.

 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.

 Ensure the high quality and timeliness of deliverables from the Biostatistics department. Oversee and ensures the high quality level of the Biostatistics expert review process.

 Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues.

 Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Biostatistics metrics, implementation of revised work practices, new guidelines, and new software tools as they become available

 Effectively allocate resources at the site level so as to achieve target utilization rates and project realization rates.

 Assist in the following: (i) sales meetings as required; (ii) overseeing proposal preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions.

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.

 

EEO Minorities/Females/Protected Veterans/Disabled

See full job details and apply at employer site