Manager, Statistical Programming

Emmes; Hinoba-an; On-site; PHP 150,000 - 250,000; Full time

Job summary

Emmes Group is seeking a Statistical Programming Manager I to lead and oversee statistical programming for complex clinical projects. You will mentor staff, ensure timely programming deliverables, and contribute to regulatory submission activities.

Applicants should have 10+ years of CDISC statistical programming experience, strong leadership, and familiarity with GCP and regulatory guidelines. The role involves cross-functional collaboration within a dynamic clinical research environment.

Qualifications

• A bachelor's or higher in a scientific field with 10+ years of statistical programming experience.
• Experience supervising a clinical research programming team and delivering regulatory submissions.
• Understanding of GCP and regulatory standards (FDA/EMA/ICH).

Responsibilities

• Provide lead or oversight statistical programming for complex projects and teams.
• Mentor and manage Statistical Programmers; ensure timely deliverables.
• Coordinate submission deliverables and maintain programming documentation.
• Present programming topics internally and at external conferences.

Skills

CDISC standards

SAS programming

Team leadership

Regulatory submissions

Code review

Cross-functional collaboration

Mentoring

Documentation

Statistical programming

R/Python familiarity

Education

Bachelor's degree in a scientific discipline

Master's/Doctoral degree (preferred)

Tools

SAS

R

Python

Job description

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 supportfor complex clinical projects and teams, and serves as a statistical programming expert. Keyresponsibilities include overseeing the work of other Statistical Programmers, ensuring the timelydelivery of clinical research programming and regulatory submission deliverables, improving programming documentation and standardization, contributing to best practices, managing staff andmentoring team members, and ensuring project resources are allocated effectively. This role plays apivotal role in project success and continuous improvement within the department.

Responsibilities

• Provides lead or oversight statistical programming support for multiple complex clinicalresearch 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 forclinical research programming deliverables which involve either CDISC standards andanalysis 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 forregulatory submission deliverables; and/or Sponsor, Regulatory, Investigator and Safetyreview meetings.
• Proactively identifies and addresses potential opportunities to improve programmingdocumentation, specifications, and standardization, offering constructive solutions within aprogram.
• Writes well-documented, efficient, and high-quality code, conducts code review, supportscross-funtional programming activities, and programming validation as needed.
• Contributes to the development and implementation of best practices, tools, andstandardized programming approaches.
• Provides direct management of staff, including participation in training, development andmentoring of staff, identification of opportunities for growth, interviewing activities and allaspects 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 statisticalprogramming tasks are completed on schedule and that each project has adequate staffinglevels.
• Other duties as assigned.

Qualifications

• 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 ICHguidance 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, timemanagement, negotiation, mentoring and planning.
• Ability to articulate complex programming and technical concepts through written and oralcommunication.
• Excellent communication, interpersonal and organization skills required for interfacing withall levels of department management.
• Self-motivated, proactive and detail oriented.
• Strong statistical programming skills in SAS, familiarity with R, Python or other relevantstatistical software considered beneficial.

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