Senior Director, Biostatistics - 806

The Senior Director, Biostatistics is a leadership position, responsible for driving, overseeing and supporting biostatistics and statistical programming activities, including but not limited to: line management, staffing and staff development/training; support of departmental financial forecasting, budgeting, and resourcing; assessment/development of policies, procedures, and processes; and support of business development and marketing activities. The Senior Director, Biostatistics will serve as a representative for company-level, global, and/or cross-functional initiatives. The Senior Director, Biostatistics is responsible for overseeing the planning, implementation, and management of clinical trials that utilize biostatistics services.

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

Qualifications:

• 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

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).