Biostatistician Manager US Remote
The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
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. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly. Primary Purpose
The Biostatistician Manager 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
Emmes only requires all US new hires in the following job categories to be fully vaccinated before their first day of employment: (i) Clinical Research Associates (CRAs), (ii) Associate CRAs, and (iii) all CRA line managers. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.
- 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:
- Work From Home Anywhere in the US
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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 characteristics.