Job Title: Principal Statistical Programmer (ADaM + TFL)
Updated: April 22, 2025
Location: India (Home-Based, Asia-Pacific)
Job ID: 25002899
Company: Syneos Health
Position Summary
Syneos Health is seeking a Principal Statistical Programmer with over 5 years of experience in clinical research to lead and oversee programming activities, ensuring the delivery of high-quality statistical outputs in Phase 2 and Phase 3 studies. The role involves working with SAS and other statistical tools to generate summary tables, listings, graphs, and derived datasets, with a focus on meeting regulatory standards, timelines, and quality requirements. The ideal candidate will also serve as a mentor and technical expert, supporting the development of CDISC-compliant deliverables and driving programming efficiency across projects.
Key Responsibilities
Lead programming activities for complex, global clinical trials using SAS to generate statistical outputs (e.g., ADaM, TFLs, datasets).
Ensure compliance with regulatory requirements (e.g., CDISC, ICH) and maintain inspection readiness.
Provide programming expertise and technical leadership, overseeing the quality and accuracy of statistical analysis plans, programming specifications, and deliverables.
Mentor and guide junior statistical programmers, developing training materials and reviewing their work for quality and compliance.
Collaborate with biostatisticians, regulatory affairs, and other departments to ensure the timely and accurate delivery of project outputs.
Manage project timelines, deliverables, and risk mitigation strategies across multiple studies.
Contribute to the development and maintenance of programming tools, macros, and standard operating procedures (SOPs) for increased efficiency.
Participate in sponsor meetings, bid defense meetings, and provide technical guidance on the use of CDISC standards (e.g., SDTM, ADaM).
Act as a subject matter expert for CDISC standards, providing guidance and training to internal teams.
Review regulatory submission requirements and ensure compliance with industry standards for deliverables (e.g., DEFINE.XML).
Required Qualifications
Education: Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and programming experience).
Experience:
Extensive programming experience using SAS (or other required software) in clinical trials, including managing multiple complex projects.
Strong knowledge of CDISC Standards (SDTM, ADaM) and experience with regulatory submissions.
Proven ability to mentor and train junior programming staff and contribute to programming process improvements.
Skills:
Strong written and verbal communication skills.
Ability to work independently and collaboratively within a team.
In-depth knowledge of statistical programming and clinical drug development processes.
Why Join Syneos Health
Join a global leader working with 94% of FDA-approved novel drugs and 95% of EMA-authorized products.
Engage in diverse and innovative projects that change lives, working with a dynamic team across 110 countries.
Foster professional development through a supportive and engaging work environment that promotes continuous growth.
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