Head of Biopharma Biostatistics

Rockville, MD, United States

Overview:

Head of Biopharma Biostatistics

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 Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others. The Head of Biopharma Biostatistics serves as a member of Emmes biopharma leadership team ensuring high-quality, on time, and on budget statistical deliverables and supporting business development activities for potential biopharma opportunities.

Responsibilities:

Designs clinical development plans, clinical trial protocols, and statistical analysis plans in collaboration with our biopharma partners.

Leads and oversees statistical deliverables including but not limited to execution of statistical analyses, interim safety and efficacy reports, clinical study reports, and scientific manuscript development.

Fosters collaborative relationship with Sponsors and Emmes project team members serving as a point of contact for project statistical deliverables.

Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings).

Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC).

Attends and presents at external statistical conferences and workshops serving as a thought leader in the biostatistics space.

Proactively uses knowledge of advanced biostatistical methodology and leading industry trends to identify and implement biostatistical best practices.

Responsible for successful delivery of biostatistics and statistical programming services to Emmes biopharma clients overseeing budget, timelines, and quality of biostatistics related deliverables.

Collaborates with global department leadership to ensure sufficient resourcing to support Emmes biopharma portfolio.

Serves as an escalation point for biostatistics related client, quality or budget concerns for biopharma projects, resolving concerns or appropriately escalating to global biostatistics and biopharma leadership.

Leads statistical only or limited scope projects including managing budgets, timelines, deliverables, and change orders.

Leads biopharma related business development activities on behalf of the global biostatistics department including but not limited to proposal, budget development, and bid defense support.

Represents the global biostatistics department as a member of Emmes biopharma leadership team and serves as a member of the global biostatistics leadership team.

Provides input into professional development and technical training standards for the global biostatistics department.

Independently leads cross-functional interactions and initiatives with other departments and global entities ensuring frequent, clear and open communication with groups outside the global biostatistics department.

Effectively supervises biostatistics and statistical programming staff providing mentorship, feedback and conducting performance reviews.

Participates in recruiting activities for new biostatistics department staff and contributes to hiring decisions.

Promotes staff participation and achieves a high degree of engagement across the global biostatistics department with a focus on staff supporting biopharma projects.

Proactively identifies high-performing staff and provides them with mentorship and opportunities for career growth.

Other duties as assigned.

Qualifications:

MS or PhD in Biostatistics, Statistics, or Epidemiology.

Typically has 12+years experience with a PhD or 15+ years experience with a MS degree in a biostatistics environment.

Management experience including interfacing with executive leadership and supervision of experienced biostatisticians and statistical programmers.

Experience with leading biostatistics related activities in the biopharma setting or in the CRO setting for biopharma clients.

Demonstrated leadership and project management experience.

Demonstrated ability to develop strategies for future growth, set goals, and communicate and implement strategies.

Ability to lead and build effective teams and foster collaboration across broad groups or functions within the organization.

Demonstrated problem-solving and analytical skills, combined with business judgment.

Impeccable integrity as a leader and role model for leadership.

Ability to effectively communicate technical concepts, both written and oral.

Strong interpersonal and communication skills required for interfacing with all levels of management.

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. 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.

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

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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.

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