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Syneos Health
Syneos Health
H1B Visa SponsorConsultingHealthcareLogistics
Syneos Health is a fully integrated biopharmaceutical solutions organization that helps clients move therapies from clinical development to commercial delivery. Its teams combine clinical, medical affairs, commercial, technology, and market insights to address changing healthcare needs and support the development and launch of important treatments worldwide.
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Principal Statistical Programmer - India Remote

Lead SAS and CDISC programming for Syneos Health’s clinical-trial and regulatory submission work. Create validated datasets, statistical outputs, and programming standards across complex global studies.

INIndiaRemoteFull-timeLeadEnglish RequiredSoftware Engineer

Description

  • Create SAS and other statistical programming code for summary tables, listings, graphs, and derived datasets
  • Verify that all outputs satisfy project specifications and quality expectations
  • Conduct validation programming and reconcile discrepancies with programmers, biostatisticians, and project teams
  • Apply relevant SOPs, work instructions, ICH guidance, and other regulatory requirements
  • Keep project documentation, testing records, verification evidence, and quality-control materials complete and up to date
  • Coordinate timelines and priorities across several concurrent projects
  • Write specifications for datasets and outputs with differing levels of complexity
  • Lead internal meetings, share information, and track assigned actions to completion
  • Complete multiple programming projects on schedule and prepare plans to mitigate delivery risks
  • Direct statistical programming activities and oversee other programming staff
  • Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs
  • Represent statistical programming in sponsor, kickoff, and bid-defense meetings
  • Coach programming staff through training, work reviews, feedback, and ongoing guidance
  • Provide technical expertise in clinical drug development, industry standards, and electronic submission requirements
  • Develop SOPs, guidelines, policies, and procedures in collaboration with biostatistics and statistical programming teams
  • Build programming tools and macros that improve standardization and efficiency
  • Provide instruction and support on CDISC Standards
  • Review SDTM and ADaM specifications and datasets, DEFINE.XML, and other CDISC deliverables for compliance
  • Engage with industry standards organizations and share relevant standards updates
  • Transfer completed deliverables
  • Handle additional work-related responsibilities as assigned

Requirements

  • Bachelor’s degree preferred in a scientific or statistical field, or an equivalent combination of education and demonstrated programming experience
  • Substantial SAS or other relevant programming experience, preferably supporting clinical trials
  • Proven ability to lead multiple complex or global projects involving statistical programming teams
  • Working knowledge of CDISC Standards as applied to regulatory submissions
  • Experience with regulatory agency submissions is preferred
  • Experience mentoring colleagues in clinical-trial processes and CDISC Standards
  • Strong written and verbal communication skills
  • Fluency in written and spoken English

Benefits

  • Opportunities for career growth and advancement
  • Supportive, engaged management
  • Training in technical and therapeutic areas
  • Recognition from peers
  • Total rewards program
  • Inclusive workplace culture
  • Limited travel may be required

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