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Advanced Clinical · 4 hours ago

Senior Director, Biostatistics

United States

Full-time

Remote

Director/Executive

12+ years exp

Advanced Clinical is a clinical development and strategic resourcing organization committed to improving the clinical experience across the drug development journey. The Senior Director, Biostatistics is responsible for leading biostatistics and statistical programming activities, overseeing clinical trial management, and ensuring quality deliverables while contributing to business development and departmental growth.

BiotechnologyConsultingHealth CareInformation TechnologyPharmaceuticalStaffing Agency

Culture & Values

Hiring Manager

Chris Thomas

Responsibilities

Responsible for P&L management of the biostatistics department, including the development of the annual budget

Ensure overall quality of all biostatistics deliverables

Day-to-day resourcing, performance management and skills development of employees

Responsible for the hiring, promotion, transfer and release of staff

Onboarding of new employees, including training on procedures and systems

Contribute to strategy for cross-functional collaboration, company growth, and provide hands-on leadership to create a results-oriented, client-focused, team environment

Coordinate the workload of the team to ensure deliverables and timelines are met

Identify and manage project risks

Implement technology solutions that improve efficiencies within the department

Attend capability and defense presentations with clients to support the development of new business

Attend proposal strategy meetings and contribute to and approve client proposals and budgets

Manage selection, implementation and utilization and maintenance of statistical software

Work closely with Operations Quality and Compliance and Quality to ensure quality and continuous process improvement throughout the project equivalent combination of education, training, and experience

Advise and consult with sponsors regarding regulatory filing requirements; represent sponsor at FDA meetings; respond to requests from regulatory agencies

Ensure adherence to company policies, SOPs, federal guidelines and GCPs

Assist as requested with strategic company initiatives

Perform other duties as requested by management

Qualification

PhD in BiostatisticsStatistical programmingClinical trial conductLeadership experienceBudget managementTeam buildingOral communicationWritten communicationOrganizational skillsAttention to detail

Required

PhD in Biostatistics, Epidemiology, Health Science, or related quantitative field, and a Master's degree in Biostatistics or equivalent combination of education and experience

Strong biostatistics and statistical programming experience, knowledge of clinical trial conduct and industry standards are required

Experience building teams, processes and systems and managing departmental and study budgets, analyzing reports, resource utilization, profitability, etc

Excellent oral and written communication skills, organizational skills, and attention to detail are required

Minimum of 12 years direct experience in Biostatistics within a CRO/ Pharma environment, working on global trials

Minimum of 4 years of leadership experience, leading global teams