Company: Syneos Health
Location: India
Experience: Extensive experience in SAS programming within a clinical trial environment
Syneos Health is a global biopharmaceutical solutions leader with 29,000 employees across 110 countries, dedicated to accelerating clinical development and improving patient outcomes.
Join us—because work here matters everywhere.
The Principal Statistical Programmer will be responsible for developing, validating, and reviewing statistical programming deliverables for clinical trials, ensuring regulatory compliance and adherence to CDISC standards. This role involves leading programming activities, collaborating with cross-functional teams, and mentoring junior programmers.
Develop SAS programming code to generate:
Summary tables, data listings, and graphs
Derived datasets for statistical analysis
Perform quality control (QC) and validation of programming outputs
Ensure regulatory compliance with CDISC standards, ICH guidelines, and sponsor requirements
Review Statistical Analysis Plans (SAP), mock shells, programming specifications, and datasets
Act as a lead programmer and direct programming activities for multiple projects
Manage timelines and deliverables, ensuring quality standards are met
Collaborate with biostatisticians, data managers, and clinical teams to resolve programming issues
Communicate project status updates and risks to stakeholders
Ensure compliance with SDTM and ADaM standards for regulatory submissions
Participate in regulatory meetings, sponsor discussions, and industry forums
Serve as a subject matter expert for CDISC standards and mentor teams on best practices
Mentor and train junior programmers in statistical programming and CDISC compliance
Contribute to developing standard operating procedures (SOPs) and programming tools
Support innovation in statistical programming methodologies
Bachelor’s or Master’s degree in Statistics, Life Sciences, or a related field
Extensive SAS programming experience in a clinical trial environment
Experience in regulatory submissions and CDISC compliance (SDTM, ADaM, DEFINE.XML)
Strong expertise in SAS programming, statistical analysis, and data management
Knowledge of ICH guidelines, regulatory requirements, and clinical trial processes
Experience working with global regulatory agencies (FDA, EMA, etc.)
Excellent written and verbal communication skills
Strong analytical skills to interpret complex clinical data
Ability to manage multiple projects and meet tight deadlines
Proactive problem-solving and leadership skills
Worked on 94% of all Novel FDA-Approved Drugs in the past five years
Collaborated on 95% of EMA-Authorized Products and 200+ studies across 73,000 sites
Competitive career growth, mentorship, and rewards program
Be part of a diverse, inclusive, and innovative workplace
If you have relevant experience, apply now or join our Talent Network for future opportunities at Syneos Health.
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