Global CDISC SME and Data Standards Leader

Cytel; Hartford (CT); On-site; USD 120,000 - 190,000; Full time

Job summary

Cytel seeks a Principal Programmer CDISC SME to work embedded with a pharmaceutical client in Hartford, CT. You will provide SME leadership on CDISC standards across trials and regulatory submissions, ensuring SDTM, ADaM, CDASH, and define.xml are implemented consistently with standards.

The role involves mentoring programmers, collaborating with statisticians, Data Management, and CROs, and guiding submission-readiness through governance and training.

Qualifications

• 7+ years of statistical programming in CRO/pharma environment.
• Hands-on experience applying CDISC standards to clinical trial and regulatory submission deliverables.
• Expertise in CDISC standards including SDTM, ADaM, CDASH, define.xml, and Reviewer’s Guides.
• Proven experience reviewing, specifying, producing, validating CDISC datasets and submission packages.
• Strong understanding of protocols, SAPs, data management plans, CRFs, and data transfer specs.
• Experience collaborating with statisticians, programming teams, Data Management, CROs to ensure submission readiness.
• Outstanding communication and leadership skills.
• Ability to lead across global teams and oversee vendor deliverables.

Responsibilities

• Provide CDISC SME expertise across studies, submissions, and standards-related activities.
• Perform SME review of datasets, annotated CRFs, define.xml, Reviewer’s Guides, and CDISC-based e-submission packages.
• Serve as CDISC consultant to study teams, statisticians, programmers, Data Management, CROs, and other stakeholders.
• Collaborate with statisticians and programming colleagues to design data structures and specifications for SDTM and ADaM datasets, tables, figures, listings, and analyses.
• Lead or contribute to production, validation, and oversight of programming deliverables to ensure submission readiness.
• Support CDISC and client standards governance, documentation, templates, and training materials.
• Provide mentorship and training on CDISC standards and best practices.
• Identify process gaps and collaborate to develop tools and processes that improve efficiency, quality, and capacity.

Skills

CDISC SME

SDTM

ADaM

CDASH

define.xml

Clinical programming

Leadership

Stakeholder guidance

Data management collaboration

Education

BSc/MSc in Computer Science/Statistics/Math

7+ years statistical programming in CRO/pharma

Tools

SAS

R

Job description

Cytel seeks a Principal Programmer CDISC SME to work embedded with a pharmaceutical client in Hartford, CT. You will provide SME leadership on CDISC standards across trials and regulatory submissions, ensuring SDTM, ADaM, CDASH, and define.xml are implemented consistently with standards.

The role involves mentoring programmers, collaborating with statisticians, Data Management, and CROs, and guiding submission-readiness through governance and training.