Associate Director, Open-Source Application Development
Everest Clinical Research
United KingdomRemote["FULL_TIME"]
Everest Clinical Research (“Everest”) is a full-service contract research
organization (CRO) providing a broad range of expertise-based clinical research
services to worldwide pharmaceutical, biotechnology, and medical device
industries. We serve some of the best-known companies and work with many of the
most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a
statistical and data management center of excellence. Building on this
foundation, Everest has successfully developed and established itself as a
full-service CRO. Everest’s Corporate headquarters are located in Ontario Canada
and US headquarters in New Jersey USA, with additional physical offices in Asia
and Europe.
Everest is known in the industry for its high-quality deliverables, superior
customer service, and flexibility in meeting clients’ needs. A dynamic
organization with an entrepreneurial origin, Everest continues to experience
exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our
strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are
seeking committed, skilled, and customer-focused individuals to join our winning
team as Associate Director, Open-Source Application Development working
remotely.
Job Accountabilities
* Provide leadership and expertise in defining, implementing, and governing
Everest's open-source application development strategy in support of clinical
data standards, statistical programming, and analytics.
* Ensure alignment with global regulatory expectations and evolving guidance
related to data standards (e.g., CDISC), automation, and advanced analytics
as reflected in internally developed tools and applications.
* Oversee the design, development, and maintenance of R- and Python-based
applications, packages, and utilities that support metadata-driven data
models for automation of downstream clinical data activities.
* Identify opportunities to streamline workflows, reduce manual effort, and
eliminate redundancies through custom-built, standardized, and automated
application solutions.
* Establish a framework that supports controlled innovation in application
development and validation lifecycle, including design specifications, coding
standards, coding review, version control, change management, and impact
assessment for new applications/tools and their releases.
* Ensure AI-assisted development approaches align with regulatory expectations,
data integrity principles, and Everest validation and documentation
requirements.
* Maintain a software development lifecycle (SDLC) framework appropriate for
open-source language-based applications, including source control practices
(e.g., GitHub or similar), branching strategy, testing standards, and release
management.
* Foster a culture that balances quality, compliance, and operational
excellence with thoughtful innovation in application development.
Qualifications and Experience
* A M.Sc., M.A. or higher in Statistics, Computer Science, or a relevant field
with at least 10 years of clinical research and industry experience.
* Demonstrated experience implementing CDISC standards for various therapeutic
areas and supporting regulatory submissions of clinical trial data.
* Strong hands-on experience with R, Python, and SAS, including application
development (not limited to scripting/analysis), package/library creation,
and software design for clinical data and statistical programming use cases.
* Demonstrated experience applying AI and large language model (LLM) tools for
coding development, including code generation, code review, testing, and
integration into applications/tools.
* Experience with GitHub or similar version control and application development
platforms (e.g., GitLab, Bitbucket), including code review workflows,
branching strategies, and CI/CD practices.
* Experience with developing and delivering training curricula is preferred.
* In-depth knowledge of clinical trial data management, statistical
programming, and analysis requirements for assembling and presenting trial
results to regulatory agencies.
* Strong written communication and presentation skills.
* Travel level specification: this position may require up to 10% business
travel.
Everest is inviting candidates to apply to this existing vacancy.
To find out more about Everest Clinical Research and to review other
opportunities, please visit our website at www.everestclinical.com
[http://www.ecrscorp.com].
We thank all interested applicants, however, only those selected for an
interview will be contacted.
Everest is committed to upholding the principles of dignity, independence,
integration, and equal opportunity. We welcome and encourage applications from
people with disabilities, and upon request we will provide accommodations for
candidates participating in any part of our recruitment and selection process.
#LI-Remote
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