Project Leader - Biostatistician

Role Description

The Project Leader - Biostatistician (PL-Stat) is critical to the successful conduct of government-sponsored clinical research projects, serving as the matrix leader of the core project team. In addition to serving as study Biostatistician, the PL-Stat is accountable for successful delivery of clients' statement of work activities within timeline and budget. The PL-Stat develops and maintains a positive relationship with clients and other external stakeholders, oversees deliverable quality, mentors staff, and works collaboratively across departments to accomplish project goals. The PL-Stat is responsible for the continuous monitoring, identification, escalation and mitigation of project risk.

• Accountable for technical, scientific, and fiscal execution of government research projects through collaboration with staff from multiple departments.
• Perform statistical duties per statistical JDs level/experience and project SOW.
• Sets priorities for the project team, ensures quality processes are followed, and collaboratively establishes and maintains deliverable timelines.
• Identifies statistical issues, proposes solutions, and consults with other statisticians across the company on project-related statistical matters.
• Serves as the primary point of contact for clients, investigators, and other stakeholders for assigned projects and/or protocols.
• Develops, reviews, and approves project plans, study documents, and processes/SOPs, as needed.
• Applies broad knowledge of therapeutic areas, clinical trial design, and process expertise to influence and execute project decisions.
• Defines and approves approaches or solutions to project requirements, risks, and issues.
• Develops, maintains, and secures approval of budgets, statements of work, and subsequent modifications prior to client distribution.
• Liaises with corporate leaders and other departments to ensure staff resources are informed, trained, and efficiently utilized.
• Represents the project in Corporate meetings and provides central status reporting and information to Executive leadership.
• Uses key performance metrics to effectively execute the project scope.
• Mentors project staff and supports staff development; may contribute to the development of new Project Leaders.
• Supports corporate knowledge expansion by participating in internal and external meetings/trainings.
• Promotes and implements corporate initiatives, as directed.
• Leads or contributes to operational strategy development, budget preparation, and proposal content for new business opportunities.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• 6 years + Master's or 3 years + PhD of empirical knowledge of the key accountabilities/duties/responsibilities for the position.
• Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment.
• Demonstratable track record of successfully delivering complex/high-priority clinical trials or clinical research projects within the agreed time, quality, and budget.
• Demonstrated working knowledge of the principles of clinical research management and operations.
• Demonstrated strong problem-solving and analytical skills, combined with sound business and ethical judgment.
• Excellent verbal and written communication skills for client, team, and scientific interactions.
• Ability to work proactively and effectively, with creative problem-solving and collaboration skills.
• Strong cross-functional project management and time management skills.
• Broad understanding of a therapeutic area, clinical trial design, and/or process expertise to influence and execute project decisions (preferred).

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment