Job Details
Summary
In this position, you will provide overall technical, administrative and functional oversight for the Biostatistics functions of the organization which include statistical consulting, statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Oversee the efficient, accurate, and timely execution of all assigned Biostatistics projects within the division.
What you will do
- Direct activities of assigned group(s) to ensure effective performance of function.
- Serve as a model to departmental subordinates as it relates to effective time management, communication, and utilization of resources.
- Provide leadership and motivation to departmental personnel.
- Interact collaboratively and cooperatively with other departmental and company staff to ensure that project and department activities are successfully completed.
- Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel.
- Actively monitor project budgets and help staff identify resourcing or scope of work changes.
- 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.
- 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.
- 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.
- 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.
- 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.
- Serve as primary statistical oversight for Biostatistics standalone or otherwise complex studies.
- Develop and review statistical analysis plans 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.
Qualifications
- Education: Master s degree (M.A., M.S.) or equivalent in Biostatistics or related field.
- Experience: 8+ years related clinical research experience
- 5+ years successfully leading statistical activities in clinical research.
- 5+ years supervisory experience required.
- Previous CRO experience required
- Other: Knowledge of the drug development process and FDA and ICH Guidelines required. Experience with regulatory submissions is preferred.