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Principal Statistical Programmer

Syneos Health
Syneos Health
4-6 years
Not Disclosed
Remote, India, India
1 May 8, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Principal Statistical Programmer
Location: India (Remote)
Company: Syneos Health
Job ID: 25108223
Job Type: Full-Time
Industry: Biostatistics / Statistical Programming / Clinical Research / Biometrics


About the Company

Syneos Health is a globally recognized and fully integrated life sciences organization dedicated to accelerating customer success across clinical development, medical affairs, and commercialization. The company collaborates with pharmaceutical, biotechnology, and healthcare innovators to support efficient drug development and improve patient outcomes worldwide.

With more than 25,000 professionals globally, Syneos Health combines scientific expertise, operational excellence, and advanced analytics to deliver impactful healthcare and clinical research solutions.


Job Overview

Syneos Health is hiring experienced professionals for the role of Principal Statistical Programmer. The selected candidate will lead complex statistical programming activities, oversee regulatory-compliant clinical data deliverables, and provide technical leadership across global clinical research projects.

This remote opportunity is ideal for candidates with advanced expertise in SAS programming, CDISC standards, SDTM, ADaM, regulatory submissions, and clinical trial data programming within pharmaceutical, CRO, or healthcare analytics environments.


Key Responsibilities

  • Develop custom programming code using SAS or related statistical software
  • Generate:
    • Summary tables
    • Data listings
    • Graphs
    • Derived datasets
    • Regulatory submission outputs
  • Perform validation programming and quality control activities to ensure compliance and data accuracy
  • Collaborate with programmers, biostatisticians, and project teams to resolve discrepancies and technical issues
  • Maintain complete and inspection-ready project documentation and validation records
  • Manage timelines and programming deliverables across multiple concurrent studies and global projects
  • Develop dataset and output specifications according to sponsor and statistical requirements
  • Review:
    • Statistical Analysis Plans (SAPs)
    • Mock shells
    • Programming specifications
    • Annotated CRFs
    • SAS database designs
  • Lead statistical programming teams and monitor programming deliverables
  • Participate in sponsor meetings, kickoff meetings, and bid defense discussions
  • Mentor junior programming professionals and support technical training initiatives
  • Maintain expertise in:
    • Clinical drug development
    • Regulatory submissions
    • CDISC standards
    • Industry programming best practices
  • Support development of:
    • Programming tools
    • Macros
    • SOPs
    • Standardization initiatives
  • Serve as a technical Subject Matter Expert (SME) for:
    • CDISC standards
    • SDTM
    • ADaM
    • DEFINE.XML
    • Regulatory compliance requirements
  • Conduct compliance reviews for regulatory deliverables and CDISC datasets
  • Participate in industry standards activities and provide updates on evolving regulatory requirements
  • Support operational efficiency and process improvement initiatives

Required Qualifications

  • Undergraduate degree in:
    • Statistics
    • Biostatistics
    • Computer Science
    • Mathematics
    • Life Sciences
    • Or related scientific disciplines
  • Equivalent programming experience may also be considered
  • Strong understanding of:
    • Clinical trial programming
    • Regulatory submission standards
    • Clinical data management
    • Statistical reporting workflows

Experience Requirements

  • Extensive experience in statistical programming within clinical trial environments
  • Proven ability to lead multiple complex or global programming projects
  • Strong expertise in:
    • SAS programming
    • CDISC implementation
    • SDTM
    • ADaM
    • Regulatory submissions
  • Experience mentoring programming teams and leading technical initiatives is highly preferred
  • Freshers are not eligible for this role