Senior Director, Biostatistics

806

Workplace Type: Remote

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.). 

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.