Principal Programmer CDISC SME FSP

Cytel; Indianapolis (IN); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to work embedded with a global pharmaceutical client. You will provide subject matter leadership on CDISC standards across SDTM, ADaM, and related submission deliverables, ensuring accuracy, traceability and regulatory readiness.

You will collaborate with statisticians, programmers and data management to design data structures, produce compliant datasets, and mentor teams while driving process improvements and governance across the programming

Qualifications

• Degree in Computer Science, Mathematics or Statistics with 7+ years of statistical programming experience.
• Extensive hands-on CDISC standards experience across SDTM, ADaM, CDASH and define.xml.
• Expert review of CDISC datasets and submission packages for regulatory readiness.
• Experience guiding study setup, data standards and dataset design with cross-functional teams.
• Strong leadership, communication and organizational skills.
• Ability to lead vendor and cross-site programming efforts with stakeholders.

Responsibilities

• Provide CDISC SME leadership for SDTM, ADaM, CDASH and submission deliverables.
• Review datasets, annotated CRFs, define.xml and submission packages for accuracy.
• Advise study teams on data standards, dataset design and submission readiness.
• Collaborate with statisticians and programming colleagues on data structures for reports and analyses.
• Lead or contribute to production, validation and oversight of programming deliverables.
• Contribute to CDISC governance, standards documentation and training materials.
• Mentor colleagues and present CDISC best practices across teams.
• Identify gaps and drive process improvements to increase efficiency and quality.

Skills

CDISC standards

Statistical programming

Leadership

Cross-functional collaboration

Communication skills

Regulatory submission readiness

Quality assurance

Mentorship and training

Education

BSc/MSc/Diploma in Computer Science, Mathematics/Statistics

Job description

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 practice.

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.

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.

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.

Cytel Inc. is an Equal Employment / ... Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.