Director – Biostatistics
Manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (FTE, utilization, and output) levels are met. May fulfill the role of site head or functional head within a site. Manage direct personnel reports typically consisting of Manager to Associate Director level staff from each function. Participate in sales meetings as required and oversees departmental proposal preparation. Monitor budget and scope of within-office projects and take action necessary to maximize realization. Ensure that departmental staff contribute to intra- and interdepartmental process improvement to achieve best practices . Ensure that appropriate levels of professional development and training are provided to staff. Serve as a biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials. Provide statistical direction, technical oversight, or consultancy on major projects or on projects involving particularly complex statistical analyses. Represent clients at FDA or other scientific meetings as required.
• 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.
• Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee.
• As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication.
• 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.
All responsibilities are essential job functions unless noted as nonessential (N).
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Master's degree in biostatistics or related field and 12 years relevant experience including 6 years’ experience managing staff; Bachelor's degree in biostatistics or related field and 15 years relevant experience including 8 years’ experience managing staff; or equivalent combination of education, training and experience
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Regular sitting for extended periods of time.
• Travel as required
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