Associate Director Biostatistics

Overview

Associate Director, Biostatistics

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

The Associate Director, Biostatistics provides leadership and subject matter expertise for the statistical design, analysis, and interpretation of clinical trial data. This role works closely with cross functional teams including clinical operations, data management, medical writing, and regulatory affairs to ensure the integrity, accuracy, and scientific rigor of statistical analyses across multiple studies and therapeutic areas. The Associate Director contributes to the strategic planning of study design and provides guidance on statistical methodology, data analysis, and reporting to support clinical development programs.

Responsibilities

• Lead and oversee the statistical analysis plan SAP development, study design, and protocol development in collaboration with cross functional teams.

• Supervise and mentor biostatisticians, providing technical guidance, training, and performance management.

• Provide statistical input for study protocols, case report form CRF design, and data collection strategies.

• Ensure high quality statistical deliverables, including tables, listings, figures, and clinical study reports.

• Conduct complex statistical analyses using appropriate methodologies for clinical trials.

• Review and approve statistical outputs, results, and programming code generated by team members.

• Collaborate with medical writing, regulatory, and clinical teams to ensure accuracy and clarity of statistical content in submissions.

• Support regulatory submissions and respond to queries from health authorities regarding statistical analyses.

• Provide strategic input for study design, sample size calculations, and adaptive trial methodologies.

• Drive process improvements and implementation of best practices in biostatistics.

• Participate in department and corporate initiatives, including SOP development, quality assurance, and methodological advancements.

• Performs other duties as assigned.

• Complies with all policies and standards.

Qualifications

• Master's Degree in Biostatistics, Statistics or a related scientific discipline or PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or a related scientific discipline.
• 7-9 years experience in biostatistics within the pharmaceutical, biotechnology, or clinical research environment.
• 4-6 years Proven experience in clinical trial design, statistical programming, and data analysis.
• 4-6 years Experience supervising or leading a team of biostatisticians.
• 4-6 years Strong knowledge of statistical software such as SAS, R, or Python
• 4-6 years Familiarity with regulatory requirements and guidance from FDA, EMA, or other health authorities.
• 4-6 years Experience with global clinical trials and multi-center studies.

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 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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