Associate Director, Statistical Programming

Associate Director, Statistical Programming

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, Statistical Programming provides lead or oversight statistical programming support for multiple large and complex clinical research projects and serves as a statistical programming expert within the department. Key responsibilities include leading cross-functional teams, identifying training and development opportunities, overseeing Statistical Programmers and Managers, contributing to process improvements, resource projections, and managing staff and mentoring team members. This role also includes project management, documentation approval, and providing high-level oversight of programming resources. Effective communication, technical expertise, and resource management are critical components of this role.

• Provides lead or oversight statistical programming support for multiple large or complex clinical research study projects or study teams, across a broad research area.
• Leads a cross-functional group that may include training and development of staff, interviewing and hiring activities, business development, department innovation, or standardization efforts.
• Serves as a statistical programming expert and identifies consultation and training opportunities within the department.
• Oversees Statistical Programmers and Programming Managers across a broad research area.
• Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, and staying up to date with tools and technologies.
• Proactively identifies and addresses potential opportunities to improve programming documentation, specifications, and standardization, offering constructive solutions within the department.
• Contributes to resource projections for the Department based on existing projects and upcoming projected work.
• Writes well-documented, efficient, and high-quality code and supports cross-functional programming activities.
• Communicates with project management regarding timelines, changes to timelines, and any organizational or technical challenges as they arise.
• Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and data submissions.
• Provides direct management and mentoring of staff, identification of opportunities for growth, staff assignments, utilization monitoring and all aspects of performance management.
• Presents statistical programming topics internally and may present at external conferences.
• Provides project updates to appropriate project management or department management staff.
• Provides high-level oversight of programming resources (i.e., budget and personnel) and utilization, and serves as a point of contact across a broad research area to ensure statistical programming tasks are completed on schedule and that each project has adequate staffing levels.
• Other duties as assigned

• Base and Advanced SAS Certification.
• A bachelor's degree plus 12 years or master's/doctoral degree plus 10 years Statistical programming experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment including 5 years' experience managing staff. Advanced degree and education in a scientific discipline preferred.
• Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and ICH guidance and recommendations) in Clinical Research.
• Good analytical skills with the ability to process scientific and medical data.
• Proven effective leadership of a clinical research team.
• Ability to manage multiple tasks and priorities of a team, while also working independently.
• Strong skills in prioritization, problem-solving, organization, decision-making, time management, negotiation, mentoring and planning.
• Ability to articulate complex programming and technical concepts through written and oral communication.
• Excellent communication, interpersonal and organization skills required for interfacing with all levels of department management.
• Self-motivated, proactive and detail oriented.
• Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial

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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