Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the
support of Cytel right behind you, you'll be at the heart of our client's
innovation. As a Principal Programmer CDISC SME you will be dedicated to one of
our global pharmaceutical clients; a company that is driving the next generation
of patient treatment, where individuals are empowered to work with autonomy and
ownership. This is an exciting time to be a part of this new program.
Position Overview:
The Principal Programmer CDISC SME provides subject matter expertise and
leadership in the application, review, and oversight of CDISC standards across
clinical studies and regulatory submission activities.
This role ensures that clinical data standards, including SDTM, ADaM, CDASH,
define.xml, annotated CRFs, Reviewer’s Guides, and related submission
deliverables, are implemented consistently, accurately, and in alignment with
client standards, regulatory expectations, and industry best practices.
The role serves as a key CDISC consultant to study teams, statisticians,
programmers, Data Management, Technology Enabled Science, Standards, CROs, and
other cross-functional stakeholders. The position provides expert review of
CDISC-based datasets and documentation, supports standardization initiatives,
contributes to process documentation and training, and ensures submission
readiness of clinical data packages.
RESPONSIBILITIES
Your responsibilities will include:
Provides CDISC subject matter expertise across clinical studies, submissions,
and standards-related activities, ensuring appropriate interpretation,
implementation, and oversight of CDISC standards, including CDASH, SDTM,
ADaM, define.xml, annotated CRFs, Reviewer’s Guides, and related submission
documentation.
Performs SME review of selected datasets, annotated CRFs, define.xml,
Reviewer’s Guides, and CDISC-based e-submission packages to ensure accuracy,
consistency, traceability, compliance with client standards, and alignment
with regulatory expectations.
Serves as a CDISC consultant to study teams, statisticians, programmers, Data
Management, Technology Enabled Science, CROs, and other stakeholders by
providing guidance on study setup, data standards, dataset design, standards
interpretation, submission readiness, and issue resolution.
Collaborates with study statisticians and programming colleagues to design
data structures and specifications for study and ad hoc deliverables,
including SDTM and ADaM datasets, tables, figures, listings, analysis
submission content, integrated summaries, and exploratory analyses.
Leads or contributes to the production, validation, review, and oversight of
programming deliverables, including work performed internally and by CROs, to
ensure quality, accuracy, traceability, and submission readiness of clinical
data and analysis outputs.
Supports and contributes to CDISC and client standards governance, including
standardization initiatives, development or review of standards
documentation, process documentation, guidance documents, templates, and
associated training materials.
Provides mentorship, knowledge sharing, presentations, and training to
programmers and cross-functional stakeholders on CDISC standards, client
standards, submission expectations, internal processes, SOPs, and best
practices for standards implementation.
Identifies process gaps, programming challenges, standards inconsistencies,
and opportunities for improvement, and collaborates with Programming
leadership and cross-functional partners to develop global tools, processes,
and practices that improve efficiency, quality, and capacity within the
Programming organization.
QUALIFICATIONS
Here at Cytel we want our employees to succeed, and we enable this success
through consistent training, development and support. To be successful in this
position you will have:
Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or
related area with 7+ years of statistical programming experience in
CRO/pharmaceutical environment.
Extensive hands-on experience applying CDISC standards to clinical trial and
regulatory submission deliverables.
Demonstrated expertise in CDISC standards, including SDTM, ADaM, CDASH,
define.xml, annotated CRFs, Reviewer’s Guides, controlled terminology,
traceability, and regulatory submission expectations.
Proven experience reviewing, specifying, producing, validating, or overseeing
CDISC-compliant datasets and submission packages, including deliverables
produced internally and by CROs.
Strong understanding of clinical trial documentation and downstream
programming requirements, including protocols, statistical analysis plans,
data management plans, CRF builds, external data transfer specifications,
dataset specifications, and analysis output requirements.
Experience collaborating with statisticians, clinical programming teams, Data
Management, Technology Enabled Science, Standards, study teams, and CROs to
ensure appropriate study setup, data standards implementation, dataset
design, and submission readiness.
Outstanding communication skills (written and verbal) and strong leadership
skills
Excellent organizational skills and ability to prioritize individual and team
workloads.
Strong ability to lead and collaborate across cross-functional, global teams,
including oversight of vendor deliverables and alignment with internal
stakeholders.