Job Title:
Principal Statistical Programmer – SDTM, ADaMs & TLFs (Consumer Health)
Company:
Syneos Health®
Location:
Remote – India
Job ID:
25101680
Updated On:
September 14, 2025
About Syneos Health
A leading integrated biopharmaceutical solutions organization with 29,000 employees across 110 countries.
Supported 94% of all FDA-approved drugs and 95% of EMA-authorized products in the past 5 years.
Offers career development, technical and therapeutic training, peer recognition, and rewards.
Promotes a Total Self culture, enabling employees to bring their authentic selves to work.
Dedicated to diversity, inclusion, and belonging across the organization.
Job Summary
The Principal Statistical Programmer will lead statistical programming activities for clinical studies in Consumer Health. This role involves:
Developing SDTM, ADaM datasets and TLFs.
Leading programming deliverables and ensuring regulatory compliance.
Acting as a CDISC standards subject matter expert.
Mentoring junior programmers and contributing to organizational efficiency through tools and macros.
Core Responsibilities
Programming & Deliverables
Develop custom SAS programs for TLFs, listings, graphs, and derived datasets per SAP/programming specifications.
Validate programming outputs and resolve findings with cross-functional teams.
Develop dataset and output specifications, including complex cases.
Ensure compliance with SOPs, WIs, ICH guidelines, and regulatory requirements.
Maintain complete, well-documented, inspection-ready programming records.
Leadership & Project Management
Serve as Lead Statistical Programmer across multiple studies.
Direct and monitor activities of programming personnel.
Negotiate programming timelines and provide risk mitigation plans.
Represent statistical programming in sponsor, kickoff, and bid defense meetings.
Ensure on-time delivery of concurrent project programming deliverables.
Collaboration & Communication
Work with biostatisticians, programmers, and other team members to ensure quality outputs.
Provide proactive updates to project teams on progress/issues.
Conduct effective internal meetings and follow up on action items.
Standards & Compliance
Review SAPs, mock shells, programming specifications, annotated CRFs, and database designs.
Provide compliance reviews for CDISC deliverables (SDTM, ADaM, Define.xml).
Participate in CDISC and industry standards organizations, updating teams on changes.
Create, validate, and submit eSub packages to FDA, including SDRG and ADRG.
Mentorship & Innovation
Mentor and train programming personnel on processes and CDISC standards.
Contribute to development of macros and programming tools to improve efficiency.
Serve as a technical expert for programming standards and regulatory requirements.
Qualifications
Experience:
8+ years in clinical SAS programming.
Strong expertise in SDTM, ADaM programming, specifications, and TLFs.
Study lead experience (managing at least 3 studies simultaneously).
Experience with eSubmissions (Define.xml, SDRG, ADRG, FDA packages).
Skills:
Excellent communication, presentation, and interpersonal skills.
Strong mentoring and leadership skills.
Deep knowledge of clinical trial processes, CDISC standards, and regulatory requirements.
Additional Information
Minimal travel required.
Tasks and responsibilities are not exhaustive and may be adjusted by the company.
Equivalent experience or education may substitute listed qualifications.
Syneos Health is committed to equal opportunity, ADA compliance, and fair employment practices globally.
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