The EMMES Corporation

Oversees statistical activities across clinical research studies, manages a team, and ensures high-quality deliverables. | Requires a PhD or MS in statistics or related field, with 4-6+ years of experience in clinical research and team leadership. | Overview Biostatistician Manager US Remote Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us! Primary Purpose Oversees statistical activities and deliverables across a project or platform of related clinical research studies, leads a team of Statisticians and SAS Programmers and ensures that statistical deliverables are completed in a timely manner and with high quality. Serves as a lead statistician on multiple clinical research studies, from the initial design stage all the way to final report writing and manuscript preparation. Responsibilities • Manages a team of Statisticians and SAS Programmers and is ultimately responsible for statistical deliverables across multiple projects or platforms of related clinical research studies. • Serves as a lead statistician on multiple clinical research studies, from initial study design through final report development and manuscript writing. • Serves as a client point of contact for statistical deliverables, fostering a collaborative relationship with contract sponsors and Emmes project team members. • Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings). • Manages project statistical resources (i.e. budget and personnel) to ensure statistical tasks are completed on schedule and that each project has adequate staffing levels. • Establishes budgets for statistical activities on new project work. • Identifies statistical and operational issues and proposes solutions. • Oversees the conduct of a clinical trial/project and quality control at the clinical center(s) and the data coordinating center and communicates issues to the appropriate oversight committees. • Prepares, reviews and/or approves clinical project material that requires statistical input to ensure that the documents are scientifically valid and feasible. • Supervises and mentors more junior statistical staff and provides opportunities for career growth. • Participates in recruiting activities for new statistical staff members and provides input on hiring decisions. • Reviews work processes, schedules and checklists to ensure that all routine activities, as documented in corporate and project-specific Standard Operating Procedures (SOPs), are efficiently performed. • Participates in project and corporate quality assurance activities, particularly those of a statistical nature. • Ensures that project staff is trained and mentored, supervises project staff and performs personnel reviews. • Provides project updates to Senior Biostatistician Managers. • Other duties as assigned Qualifications • MS or PhD in statistics, biostatistics, epidemiology or related field. • At least 4 (with PhD) or 6 (with MS) years of related experience; including leading a clinical research team and supervising senior level statistical staff. • Expertise in state-of-the-art data manipulation and statistical analyses. • Proven effective leadership of a clinical research team. • Strong skills in prioritization, problem-solving, organization, decision-making, time management, negotiation, mentoring and planning. • Self-motivated, proactive and detail oriented. • Demonstrated ability to manage multiple tasks, while working independently. • Ability to effectively communicate technical concepts, both written and oral. Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: • Flexible Approved Time Off • Tuition Reimbursement • 401k Retirement Plan • Work From Home Anywhere in the US • Maternal/Paternal Leave • Casual Dress Code & Work Environment CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status. #LI-Remote

Manage and deliver projects by coordinating teams, overseeing schedules, budgets, risks, and ensuring quality and client satisfaction. | Requires 5-8 years project management experience, bachelor’s degree, proficiency in PM methodologies and tools, leadership skills, and strong communication. | Overview: Project Manager II - Essex Management US Remote This position supports "Essex, an Emmes Company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors. Primary Purpose The Project Manager 2 position fulfills a key role within Essex, responsible for project management delivery that aligns Essex’s PM methodologies and our organizational mission, vision, and strategic priorities. This role oversees project initiation, development, and implementation across client and Essex project initiatives. Builds collaborative and trusted relationships, providing guidance to project teams and client / stakeholder groups, ensuring project delivery performance and quality, risk management, and client satisfaction while fostering cross-functional collaboration to maximize value. The role partners with portfolio management, program managers, and divisional leaders to ensure alignment, accountability, and effective project lifecycle management. Supports organizational reporting to enable decision-making and strategic planning. Maintains awareness of industry best practices and emerging trends in project management, contributing to Essex’s PM methodologies and continuous improvement. Essex employees may be required to travel per client request or contract requirements. Responsibilities: • Demonstrate knowledge of Essex’s approach to project management, following a standard approach on Essex engagements • Collaborate with project teams to achieve contractual / project goals and objectives, delivering according to scope, schedule, and budget • Anticipate potential barriers, identify project risks and mitigation strategies to avoid issues / project impacts • Understand and adhere to Essex and client governance structures and processes established for assigned projects • Assist with creating and updating project documentation, including project management plans, project schedule, RACI, communication plan, risk register, decision and action trackers, project dependencies, and any other project / contract specific requirements • Organize and facilitate project communications, develop and distribute communications material (e.g., presentations, meeting summaries, action trackers) • Engage with internal and external stakeholders to assist with gathering business requirements / use cases, facilitating prioritization, building support and maintaining transparency • Management and delivery of monthly status reports and project specific reporting requirements and associated documentation • Ensure quality assurance for project delivery activities in accordance with contractual requirements and key performance indicators • Complete required Essex and client trainings; maintain awareness of Essex and client policies to ensure ongoing compliance Required Skills Technical Skills: • Proficiency in project management methodologies (e.g. SDLC, Agile, Scrum, Waterfall, Lean) • Competency using MS Office and other project management and visualization tools (e.g., MS Project, MS Power Suite, Confluence, Jira, GitHub) • Experience with budget management, supports LOE estimates, staff plans, and forecasts, providing budget oversight and financial tracking • Skilled in identifying, analyzing, and mitigating project risks, escalating issues as needed to clients / leadership as needed for support • Knowledge of quality assurance and management practices, supporting of process and SOP development Management Skills: • Independently manage projects of moderate complexity • Strong leadership skills to motivate and guide project teams, with minimal guidance from the program/project lead • Effective project planning and organization skills, with the ability to create detailed project plans, timelines, and schedules. • Competence in making timely and informed decisions, and ability to adapt easily to change • Skilled in resolving conflicts and negotiating with project team members and stakeholders Interpersonal Skills: • Excellent verbal and written communication skills, focused and engaged listener • Ability to work effectively with a project team, with cross-functional teams and as part of a matrix organization • Skilled in stakeholder management, building and maintaining relationships, ensuring business needs and expectations are met • Customer focused and committed to delivering high-quality services and ensuring customer satisfaction Qualifications: • Bachelor’s degree required in a business, management, engineering, or a related field. • 5-8 years prior project management experience required; including leading multiple projects from initiation to completion • Experience working on Federal government projects desired • PMP certification desirable, but not required More about The Emmes Group Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us! Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: • Flexible Approved Time Off • Tuition Reimbursement • 401k Retirement Plan • Work From Home Anywhere in the US • Maternal/Paternal Leave • Casual Dress Code & Work Environment CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status. #LI-Remote