1113# Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant (Remote)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

About the Role

We are seeking a highly experienced professional to join our team as a Principal Programmer– CDISC Compliance & FDA Submission Conformance. In this role, you will be responsible for ensuring that clinical data deliverables meet FDA regulatory requirements, CDISC (SDTM and ADaM) standards, and the FDA Technical Conformance Guide (TCG). This position requires deep expertise in performing compliance and conformance checks for submission data packages and providing standardized guidance to biotech companies on FDA submission expectations.

Key Responsibilities

• Review and validate clinical data submission packages to ensure compliance with FDA Technical Conformance Guide (TCG), CDISC standards, and regulatory requirements.
• Perform comprehensive conformance checks of SDTM and ADaM datasets, ensuring accuracy, consistency, and adherence to industry standards.
• Collaborate with statistical programming, biostatistics, data management, and regulatory teams to identify, troubleshoot, and resolve compliance issues.
• Provide standardized guidance to biotech companies on FDA submission requirements, best practices, and expectations.
• Ensure submission deliverables are audit-ready, fully compliant, and aligned with regulatory timelines.
• Act as a subject matter expert in FDA TCG, CDISC implementation, and submission conformance activities.
• Mentor and guide team members on CDISC compliance, conformance checking tools, and regulatory submission processes.

Qualifications & Skills

• Advanced degree in Statistics, Computer Science, Life Sciences, or related field (Master’s or PhD preferred).
• 8+ years of experience in statistical programming, data standards, or regulatory compliance within the pharmaceutical/biotech industry.
• Strong expertise in CDISC standards (SDTM, ADaM) and FDA submission requirements, including the FDA Technical Conformance Guide (TCG).
• Proven hands-on experience in performing compliance and conformance checks for submission data packages.
• Proficiency in SAS programming and familiarity with conformance checking tools (e.g., Pinnacle 21, Define.xml validation).
• Strong problem-solving skills with the ability to provide clear guidance to cross-functional teams.
• Excellent communication and stakeholder management skills.

Preferred Experience

• Prior experience as a Principal Programmer, Principal Data Standards Specialist, or equivalent.
• Experience with global regulatory submissions (FDA, EMA, PMDA).
• Demonstrated ability to work independently and lead compliance/conformance review activities.
• Familiarity with eCTD structure and submission publishing workflows is a plus.

The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Principal#Contract Apply tot his job Apply To this Job