Biostatistician -Project Leader

Rockville, Maryland
Nov 04, 2020
Dec 03, 2020
Full Time
The Emmes Company, LLC is searching for a Biostatistician - Project Leader located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia Office. Emmes provides flexibility for office location or work remote preference dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Project Leader-Biostatistician is accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business. Provides statistical guidance and direction to project.

  • Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance
  • Identifies statistical issues, proposes solutions and consults with other statisticians throughout the company on project-related statistical issues
  • Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies
  • Reviews, provides input on, and approves project and study documents and processes, as needed
  • Represents the project or company at client meetings and scientific conferences
  • Utilizes broad understanding of therapeutic, clinical trial design, statistical and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field
  • Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables
  • Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients
  • Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients
  • Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements
  • Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
  • Uses established key performance metrics to assure successful delivery of the project that meet client requirements
  • Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities
  • Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units
  • Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations
  • Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate
  • Contributes to the development of operational strategy, budget, and proposal content for new business opportunities

  • PhD in Biostatistics, Statistics, Epidemiology with at least 3 years of relevant work experience to include management experience
  • Demonstrated working knowledge of the principles of clinical research management
  • Demonstrated experience in applying statistical expertise to the design and analysis of clinical research studies
  • Experience in protocol development, statistical analysis, and manuscript writing
  • Demonstrated leadership and project management experience
  • Strong programming abilities in SAS and/or R
  • Excellent verbal and written communication skills
  • Excellent problem solving and collaboration skills
  • Subject matter expertise in respective area of specialization
  • Demonstrated excelling project leader skills


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected

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