Veridix AI is the technology, data, and AI arm of the Emmes Group, a leading full-service contract research organization (CRO) with over 47 years of experience in supporting clinical research across more than 70 countries. With industry-leading capabilities in cell and gene therapy, vaccines, infectious diseases, and ophthalmology, Emmes is one of the top clinical service providers to the U.S. government and is rapidly expanding its presence in biopharma. Veridix AI develops advanced eClinical solutions, powering clinical trials through patient data collection, randomization, biospecimen tracking, and data quality monitoring. Our cutting-edge AI innovations, including Generative AI (GenAI) capabilities, are transforming clinical trial timelines by streamlining processes from document authoring to automating study builds. Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity. If you share our motivations and passion in research, come join us!
Project Leader - Biostatistician
Location
United States
Posted
5 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Project Leader - Biostatistician
Emmes Group
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. - Project Delivery Track Record: Demonstratable track record of successfully delivering complex/high-priority clinical trials or clinical research projects. - Clinical Research Knowledge: Demonstrated working knowledge of the principles of clinical research management and operations. - Problem-Solving: Demonstrated strong problem-solving and analytical skills. - 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. - Project Management: Strong cross-functional project management and time management skills. - Therapeutic Expertise (Preferred): Broad understanding of a therapeutic area, clinical trial design, and/or process expertise. 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
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