Project Leader - Biostatistician

Emmes Group•Rockville, MD

8d•Remote

About The Position

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. In addition to successful completion of statistical leadership responsibilities, the PL-Stat is responsible for the above named project leadership activities as an integral contributor to project success.

Requirements

6 years + Master's or 3 years + PhD of empirical knowledge of the key accountabilities/duties/responsibilities for the position with a typical tenure of at least 3 years project management experience in a research environment.
Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment
Project Delivery Track Record: Demonstratable track record of successfully delivering complex/high-priority clinical trials or clinical research projects within the agreed time, quality, and budget. Experience in federally-funded research is preferred.
Clinical Research Knowledge: Demonstrated working knowledge of the principles of clinical research management and operations.
Problem-Solving: Demonstrated strong problem-solving and analytical skills, combined with sound business and ethical judgment.
Communication: Excellent verbal and written communication skills for client, team, and scientific interactions.
Leadership & Teamwork: Ability to work proactively and effectively, with creative problem-solving and collaboration skills. Highly motivated with the ability to work independently and as part of a multi-disciplinary team. Ability to supervise, mentor, and support lower-level project leaders and staff.
Project Management: Strong cross-functional project management and time management skills.

Nice To Haves

Therapeutic Expertise (Preferred): Broad understanding of a therapeutic area, clinical trial design, and/or process expertise to influence and execute project decisions.

Responsibilities

Accountable for technical, scientific, and fiscal execution of government research projects through collaboration with staff from multiple departments, including Clinical Operations, Biostatistics, Clinical Data Management, Clinical Data Systems, Program Management, IT, Web Development, Finance, Contracts, Regulatory, and Pharmacovigilance.
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. May provide performance-related feedback to department managers for project staff.
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. Proactively addresses client needs for ongoing studies and engages clients regarding new opportunities.
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 while considering client needs, budget, scope, and the research field. With team input, defines solutions that meet client needs within project-defined scope.
Defines and approves approaches or solutions to project requirements, risks, and issues. Communicates risks and contingencies to clients and internal Government Delivery oversight.
Develops, maintains, and secures approval of budgets, statements of work, and subsequent modifications prior to client distribution, as well as invoices and subagreements.
Liaises with corporate leaders and other departments to ensure staff resources are informed, trained, and efficiently utilized to support execution of the project scope.
Represents the project in Corporate meetings (e.g., project reviews) and provides central status reporting and information to Executive leadership, as applicable.
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. Models Emmes values of integrity, accountability, collaboration, innovation, and perseverance.
Supports corporate knowledge expansion by participating in internal and external meetings/trainings and sharing insights and best practices with project teams, service groups, and other corporate stakeholders.
Promotes and implements corporate initiatives, as directed.
Leads or contributes to operational strategy development, budget preparation, and proposal content for new business opportunities. Represents Emmes at proposal meetings, business development activities, conferences, or other events, as requested.
Performs other duties as assigned.
Complies with all policies and standards.