Biostatistician Manager - Remote

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

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 :

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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.

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