Manager Statistical Programming

Overview

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 Statistical Programming Manager I provides lead or oversight statistical programming support for complex clinical projects and teams, and serves as a statistical programming expert. Key responsibilities include overseeing the work of other Statistical Programmers, ensuring the timely delivery of clinical research programming and regulatory submission deliverables, improving programming documentation and standardization, contributing to best practices, managing staff and mentoring team members, and ensuring project resources are allocated effectively. This role plays a pivotal role in project success and continuous improvement within the department.

Responsibilities

• Provides lead or oversight statistical programming support for multiple complex clinical research study projects or study teams.
• Serves as a statistical programming expert and provides support through coordination of consultation and/or training for study projects.
• Oversees Statistical Programmers for at least one project or team and is responsible for clinical research programming deliverables which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures.
• Oversees Statistical Programmers for at least one project or team and is responsible for regulatory submission deliverables; and/or Sponsor, Regulatory, Investigator and Safety review meetings.
• Proactively identifies and addresses potential opportunities to improve programming documentation, specifications, and standardization, offering constructive solutions within a program.
• Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-funtional programming activities, and programming validation as needed.
• Contributes to the development and implementation of best practices, tools, and standardized programming approaches.
• Provides direct management of staff, including participation in training, development and mentoring of staff, identification of opportunities for growth, interviewing activities 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.
• Manages project programming resources (i.e. personnel) and utilization to ensure statistical programming tasks are completed on schedule and that each project has adequate staffing levels.
• Other duties as assigned.
  
  

• A bachelor's degree or master's/doctoral degree with 10+ years Statistical programming experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment, education in a scientific discipline and previous supervisory experience 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.