Director Biostatistics

Summary:

We are currently seeking a Director, Biostatistics to join our growing team. In this role you will develop and implement statistical analysis plans, protocols, study reports, statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Additionally, you will be responsible for identifying and leading efforts for the development of the team. Previous work experience at a CRO is required.

What you will do:

• Develops and implements a strategic plan for the biostatistics sub-function that aligns with the vision and goals of the department. Assist in the development of short- and long- range operating objectives, budget, organizational structure, and staffing requirements. Assist in the development of a departmental plan for backup and succession of key departmental personnel.
• Aligns business development opportunities with the strategic plan, including serving as proposal design lead, technical writer and/or review, as necessary.
• Determines staffing needs of the biostatistics sub-function and systems for biostatistical research and reporting. Actively monitor project budgets and help staff identify resourcing or scope of work changes.
• Reviews scientific proposals, study protocols, papers, and final study reports to assure the appropriate use of statistical and reporting procedures and interpretation.
• Oversees the work of the biostatistics staff in the design and implementation of analysis plans for research studies to assure that sound analytical procedures are efficiently applied.
• Represents the department on committees, cross-functional meetings, and audits. Interact collaboratively and cooperatively with other departmental and company staff to ensure that project and department activities are successfully completed.
• Advocate the departmental team approach for effective management of broad-based projects such as NDA submissions or complex, multi-protocol programs potentially coordinating activities across multiple locations.
• Evaluates current statistical methodologies and regulatory guidance to promote continual innovation in statistical design and compliance with regulatory expectations.
• Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Serve as primary statistical oversight for Biostatistics standalone or otherwise complex studies.
• Develop and review statistical documents including protocols, statistical analysis plans, analyses and study reports based on study specific documents and sound statistical methodology.
• Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
• Provide accurate and timely status updates to other team members, colleagues, and senior management.
• Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, and client meetings/presentations.
• Assist in the development, maintenance, and communication of departmental systems and SOPs.
• Monitor and provide daily supervision and review work of assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures. Provide effective leadership and motivation to departmental personnel.
• Identify training and development needs of direct reports. Assist in the development, implementation, and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training.

Who we are looking for:

• Master's degree in Biostatistics or related field.
• 8+ years leading statistical activities in a clinical research environment.
• 5+ years of supervisory experience required.
• Knowledge of the drug development process and FDA and ICH Guidelines required.
• Experience with regulatory submissions is highly preferred.
• Knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research required. Effective oral and written communication of statistical concepts and results required.
• Effective team player: willingness to go the extra distance to get results and meet deadlines.
• Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
• Leadership skills in priority evaluations, adapting to change, conflict resolution, and effective partnership. Ability to successfully develop employee’s growth.
• Knowledge of one or more statistical software packages used to conduct statistical analyses required.