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Overview

Director, Biostatistics

CA 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

Provides leadership and oversight of the Biostatistics Department by ensuring that Emmes provides high level of quality in statistical deliverables, and in fostering career growth and development for Biostatistics Department staff.

Responsibilities

• Leading operational activities of the Biostatistics Department.
• Communicating corporate goals to the Biostatistics Department and modeling corporate culture through vision, action, and learning.
• Identifying and tracking Biostatistics Department Objectives and Key Results.
• Exhibiting knowledge of advanced biostatistical methodology and industry trends and proactively using this knowledge to identify and implement biostatistical best practices.
• Keeping abreast of and ensuring compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations).
• Defining, promoting, and monitoring quality standards for biostatistical deliverables, including creation and maintenance of SOPs.
• Providing direct supervision of Biostatistician Managers and Senior Biostatistician Managers.
• Providing support to the Therapeutic and Research Units, Business Development, Proposal, and Pricing Departments to appropriately resource and price new business opportunities for tasks within the scope of the Biostatistics Department.
• Establishing professional development and technical training standards for the Biostatistics Department and managing the professional development and training budget.
• Serving as an escalation pathway for staffing misalignment or quality issues within the Biostatistics Department.
• Assisting the EVP of Statistical and Scientific Innovation with evaluation of M&A targets or potential partnerships and integration of biostatistical staffing.
• Making staffing assignments that are responsive to project and Therapeutic and Research Unit needs, both temporary and permanent.
• Overseeing hiring of new Biostatisticians and SAS Programmers.
• Promoting staff participation and achieving a high degree of engagement across Biostatistics Department.
• Proactively identifying high-performing Biostatisticians and SAS Programmers and providing them with opportunities for career growth.
• Ensuring relevant communication flows down to all Biostatistics Department staff to encourage staff engagement.
• Ensuring frequent, clear and open communication with groups outside the Biostatistics Department.
• Contributing to analysis and manuscript development of research studies.

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 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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