Principal Statistical Programmer – ADaM/TLF (Oncology)
Job ID: 25104090
Location: Remote – India
Employment Type: Full-Time | Consulting
Company: Syneos Health®
Updated: December 29, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. Leveraging unique clinical, medical affairs, and commercial insights, we deliver outcomes that meet modern healthcare and regulatory needs.
Our Clinical Development model focuses on placing patients and customers at the center, while continuously improving workflows to enhance efficiency and collaboration. With 29,000 employees across 110 countries, Syneos Health combines global expertise and innovation to drive impactful clinical solutions.
Role Overview
The Principal Statistical Programmer – ADaM/TLF (Oncology) will lead the development of statistical programs and deliverables for oncology clinical trials. This role involves designing and validating datasets, generating tables, listings, and figures (TLFs), ensuring regulatory compliance, and mentoring programming teams.
The position requires advanced technical expertise in SAS programming, CDISC standards (SDTM/ADaM), and clinical trial processes, with a strong focus on oncology trials.
Key Responsibilities
Statistical Programming & Deliverables:
Develop and validate SAS programs to generate ADaM datasets, TLFs, and derived datasets according to statistical analysis plans.
Review and provide feedback on project documentation including Statistical Analysis Plans (SAPs), mock shells, programming specifications, and annotated CRFs.
Perform quality checks and ensure outputs meet internal standards and regulatory requirements.
Manage project timelines across multiple concurrent trials, proactively reporting issues and proposing risk mitigation strategies.
Leadership & Mentoring:
Serve as lead statistical programmer, directing the activities of other programming personnel.
Mentor junior programmers on clinical trial programming, CDISC standards, and best practices.
Conduct internal meetings, distribute agendas and minutes, and ensure follow-through on action items.
Regulatory Compliance & Standards:
Maintain expertise in CDISC standards and regulatory agency requirements (FDA, EMA), ensuring compliance in all deliverables including DEFINE.XML.
Serve as a subject matter expert, providing guidance and training on CDISC and industry standards.
Participate in sponsor meetings, project kickoffs, and bid defense meetings as the programming representative.
Process Improvement & Documentation:
Contribute to SOP development, programming guidelines, and technical tools for efficiency and standardization.
Maintain organized and inspection-ready project documentation.
Recommend process improvements to enhance efficiency and data quality.
Collaboration & Communication:
Work closely with biostatisticians, project teams, and other departments to resolve discrepancies and ensure high-quality outputs.
Act as a technical resource within the department for complex programming and regulatory questions.
Required Qualifications
Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and programming experience.
Extensive experience in SAS programming within clinical trial environments, including leadership of complex and/or global projects.
Strong knowledge of CDISC standards (SDTM, ADaM) and experience with regulatory submissions preferred.
Demonstrated experience in mentoring and training programming personnel.
Excellent verbal and written communication skills in English.
Skills & Competencies
Expert-level SAS programming and statistical analysis understanding.
Knowledge of oncology clinical trial processes.
Strong project management, organizational, and multitasking abilities.
Proficiency in preparing TLFs, ADaM datasets, and DEFINE.XML files.
Ability to provide technical leadership and guidance across multiple teams and projects.
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