Biostatistics Director

Summary of The Position:

The Biostatistics Director is responsible for the direction, strategy, and performance standards for Biostatistics activities (including the planning, execution, monitoring, and reporting of international clinical trials) within FHI Clinical Inc. Leads and mentors the biostatistics team, maintaining the appropriate resources to meet contractual obligations while ensuring adherence to quality management practices. In collaboration with the Data Sciences team, interact proactively with clients on Data Management and related issues as they arise. Provides strategic direction ensuring that the organization and conduct of regulatory and non-regulatory clinical programs is in compliance with policies and procedures, Regulatory Authority requirements and guidelines, and International Council for Harmonization (ICH) Guidelines in support of global business objectives.

The Biostatistics Director oversees training and provides leadership, support and management for the respective teams within their department, to ensure that the department’s deliverables meets the client’s time, quality and cost expectations.

Essential Functions:

• Meets and/or communicates regularly with the Global Leadership for general updates on Biostatistics activities, any changes to applicable local and international legislation and guidelines, changes within the organization, and Client’s Procedural Documents and Quality Assurance issues.
• Planning resources for awarded, potential and re-allocated studies.
• Working with the applicable project managers to recognize revenue monthly.
• Ensuring adequate, appropriately trained personnel resources are available to perform contracted projects to the highest possible standard.
• Ensuring that training of functional reports is appropriate.
• Facilitating the training and personal development of the Biostatistics Staff.
• Monitoring adherence to the FHI Clinical directives.
• Ensuring activities meet and are integrated with the organizational requirements for qualified management.
• Proactively project resource needs to ensure appropriate staffing to meet client project objectives.
• Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed client expectations.
• Communicate with team members regarding train conduct as it relates to Data Management and Biostatistics timelines and quality/
• Oversee the preparation of post-processing of data sets to Clinical Data Interchange Standards Consortium (CDISC) specifications when required.
• Ensure, in collaboration with Global Leadership, that hardware and software components are continuously updated where appropriate and adequate to meet the dynamic requirements of all tasks at hand.
• Manages senior staff and oversees the management of other biostatistics staff, ensuring alignment with strategic and programmatic goals and that performance meets and exceeds business and personal objectives.
• Oversees/participates in the implementation of sponsor and investigator meetings, conferences, and workshops.
• Provides key leadership and expertise in client presentations and bid defense meetings.
• Supports efforts for generating business leads (client networking, public speaking, etc.).
• Provides leadership to proposals for project bids to incorporate biostatistics area expertise and to ensure that projects can be successfully implemented.
• Engages in strategic planning activities and implements strategic decisions into operational plans for the Company.
• Monitors overall portfolio, key milestones, and deliverables; ensures consistent, accurate reporting to stakeholders as needed.
• Recognizes systemic issues at the portfolio level, identifies solutions with project teams, recommends actions to improve inefficiencies, and oversees the implementation of best practices.
• Acts as the escalation point for any client or implementation-related issues within the portfolio; determines and executes resolution, working with leadership as needed.
• Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
• All other duties as assigned.

Knowledge, Skills, and Abilities

• Proven ability to lead an international cross functional clinical operations team.
• Exhibits an open and constructive leadership style.
• Deep knowledge of clinical trial management techniques and tools.
• Extensive knowledge of global clinical trials management environment.
• Knowledgeable and experience with Clinical Trial Management Systems.
• Proven experience in trial management, risk mitigation, and change management.
• Able to work closely with Finance Management to understand customer’s needs, study budgets and forecasting.
• Extensive knowledge of international clinical research regulatory guidance documents and regulations.
• Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
• Good computer skills, including knowledge and experience of Microsoft Office applications.
• High degree of accuracy and attention to detail.
• Well-developed oral and written communication skills.
• Proven ability to lead an international cross-functional clinical research team.
• Exhibits an open and constructive leadership style.
• Deep knowledge of clinical trial management techniques and tools.
• Extensive knowledge of global clinical trials management environment.
• Knowledgeable and experience with Clinical Trial Management Systems.
• Proven experience in trial management, risk mitigation and change management.
• Able to work closely with Finance Management to understand customer’s needs, study budgets and forecasting.
• Extensive knowledge of international clinical research regulatory guidance documents and regulations.
• Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
• Good computer skills, including knowledge and experience of Microsoft Office applications.
• High degree of accuracy and attention to detail.
• Well-developed oral and written communication skills.

Position Requirements

Education: Education: Master’s Degree or its international equivalent in the field of Science, Statistics, Biotechnology or Biostatistics or related field preferred. Bachelor’s Degree, or its international equivalent in the field of Science, Biotechnology or Biostatistics or related field required. .

Preferred Job-related Experience: Requires 10 years of experience in Data Management or biostatistics in a clinical research setting with strong proficiency in SAS Programming. Five (5) or more years of leadership and management experience, including multi-regional and global focus.

Additional Eligibility Qualifications: Advanced skills in multiple statistical areas and/or therapeutic indications. Advanced knowledge in statistical aspects of study design. Advanced experience providing statistical consultation to researchers.

Preferences: Relevant certifications in the area of clinical trials and/or project management. Articulate, professional, and able to communicate clearly and positively with clients and staff.

Special Position Requirements: Must be able to read, write, and speak fluent English, fluent in the host country language as appropriate.

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time.
• Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements:

Expected travel time is 10% for this position.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.