Principal Statistical Programmer – SDTM, ADaMs & TLFs (Consumer Health)
Location: IND-Remote
Updated: September 14, 2025
Job ID: 25101680
Company Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success by translating clinical, medical affairs, and commercial insights into impactful outcomes.
Clinical Development model centers around patients and customers
Continuous efforts to simplify processes, making Syneos Health easier to work with and for
Collaborative environment where teams innovate to deliver therapies faster and improve lives
Global Footprint:
29,000 employees across 110 countries
Supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years
Managed 200+ studies across 73,000 sites with 675,000+ trial patients
Learn more: www.syneoshealth.com
Why Syneos Health
Career Development: Technical and therapeutic area training, mentorship, peer recognition
Inclusive Culture: Total Self culture allowing authenticity, diversity, and belonging
Collaborative Environment: Cross-functional teamwork and innovation
Role Summary
As a Principal Statistical Programmer, you will:
Lead programming activities for SDTM, ADaM, and TLF deliverables in clinical trials
Develop, validate, and review SAS programs and outputs according to statistical analysis plans and specifications
Ensure adherence to CDISC standards, SOPs, WIs, and regulatory guidelines (ICH, eSub requirements)
Mentor and guide junior programmers and serve as a technical subject matter expert
Key Responsibilities
Programming & Analysis:
Develop custom SAS code to generate datasets, summary tables, listings, and graphs
Perform validation programming and resolve discrepancies with statisticians and project teams
Create and validate ADaM/SDRG/ADRG datasets, TLFs, and define.xml files
Prepare eSubmission packages for regulatory authorities (FDA, EMA)
Project Management:
Manage multiple concurrent projects, timelines, and priorities
Track progress, report issues, and provide risk mitigation plans
Lead programming meetings, distribute minutes, and follow through on action items
Technical Expertise & Compliance:
Review SAPs, mock shells, programming specifications, and annotated CRFs
Provide CDISC guidance and ensure regulatory compliance of all deliverables
Contribute to development of programming tools, macros, and SOPs
Participate in sponsor meetings, bid defenses, and kickoff sessions as needed
Mentorship & Collaboration:
Train and mentor junior programmers on clinical trials and CDISC standards
Collaborate with biostatistics, programming, and cross-functional teams
Serve as a subject matter expert for clinical programming, regulatory standards, and industry best practices
Qualifications & Experience
Experience: 8+ years in clinical SAS programming
Technical Skills: SDTM, ADaM programming, TLF generation, define.xml creation, eSub packages
Project Leadership: Study lead experience managing ≥3 studies simultaneously
Regulatory Knowledge: eSub experience, compliance with CDISC standards
Soft Skills: Excellent communication, presentation, interpersonal skills
Mentorship: Experience guiding team members in clinical trial processes and CDISC standards
Additional Information
Tasks and responsibilities may be assigned at the company’s discretion
Equivalent experience, skills, and education will be considered
Compliance with local employment legislation, accessibility requirements, and ADA
Minimal travel may be required
How to Apply
Apply directly through the Syneos Health careers portal
Not ready to apply? Join the Talent Network to stay connected with future opportunities
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