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Syneos Health

Principal Statistical Programmer

Syneos Health

. Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets .

Posted 9/21/2026full-timeRemote • IndiaLeadWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive programming expertise in SAS and other software for clinical trial data analysis, with a strong focus on CDISC Standards and regulatory compliance. Capable of leading complex projects, mentoring programming personnel, and ensuring high-quality outputs through effective communication and documentation.

Highest-signal resume keywords
SAS ProgrammingCDISC StandardsStatistical Programming LeadershipRegulatory Submissions ExperienceMentoring in Clinical Trials

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Custom Programming Code DevelopmentValidation ProgrammingStatistical Analysis Plans ReviewProgramming Tools and Macros DevelopmentQuality Control Materials MaintenanceData Listings GenerationGraphs CreationDerived Datasets GenerationCompliance Reviews of CDISC DeliverablesProject Documentation Management
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationTeam LeadershipCollaborationTraining and Feedback
Industry Keywords
Clinical Drug DevelopmentICH GuidelinesSOPsWIsStatistical ProgrammingBiostatisticsElectronic Submission RequirementsSDTMADaMDEFINE.XML

About the role

Key responsibilities & impact
  • Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets
  • Ensure outputs meet quality standards and project requirements
  • Perform validation programming and resolve discrepancies with programmers, biostatisticians, and project team members
  • Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH
  • Maintain complete, current project documentation, testing, verification, and quality-control materials
  • Manage schedules and priorities across multiple concurrent projects
  • Develop specifications for datasets and outputs of varying complexity
  • Conduct internal meetings, distribute information, and follow action items through completion
  • Deliver concurrent programming projects on time and provide risk-mitigation plans
  • Lead statistical programming activities and direct other programming personnel
  • Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs
  • Participate in sponsor, kickoff, and bid-defense meetings as the statistical programming representative
  • Mentor programming personnel through training, work review, feedback, and guidance
  • Serve as a technical expert on clinical drug development, industry standards, and electronic submission requirements
  • Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming personnel
  • Develop programming tools and macros for standardization and efficiency
  • Provide guidance and training on CDISC Standards
  • Perform compliance reviews of CDISC deliverables, including SDTM and ADaM specifications and datasets and DEFINE.XML
  • Participate in industry standards organizations and communicate updates on standards
  • Transfer deliverables
  • Perform other work-related duties as assigned

Requirements

What you’ll need
  • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment
  • Ability to lead multiple complex and/or global projects with teams of statistical programmers
  • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
  • Experience in submissions to a regulatory agency preferred
  • Experience in mentoring others in clinical trial process and CDISC Standards
  • Excellent written and verbal communication skills
  • Ability to read, write, speak and understand English

Benefits

Comp & perks
  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition
  • Total rewards program
  • Inclusive culture
  • Minimal travel may be required