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Principal Statistical Programmer (Clinical Pharmacology)

Syneos Health
Syneos Health
2-5 years
Not Disclosed
Gurugram, India
1 May 8, 2026
Job Description
Job Type: Hybrid Education: None Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Principal Statistical Programmer (Clinical Pharmacology)
Location: Gurugram (Hybrid)
Company: Syneos Health
Job ID: 25107846
Job Type: Full-Time
Industry: Biostatistics / Statistical Programming / Clinical Research / Clinical Pharmacology


About the Company

Syneos Health is a globally recognized and fully integrated life sciences organization focused on accelerating customer success across clinical development, medical affairs, and commercialization. The company collaborates with pharmaceutical, biotechnology, and healthcare innovators to support faster and more efficient drug development 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 (Clinical Pharmacology). The selected candidate will lead complex statistical programming activities, oversee programming deliverables, support regulatory submissions, and provide technical leadership across clinical pharmacology and global clinical research projects.

This opportunity is ideal for candidates with advanced expertise in SAS programming, CDISC standards, ADaM, SDTM, regulatory submissions, and clinical trial data analysis within pharmaceutical, CRO, or clinical research 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 ensure compliance with quality standards and project requirements
  • Collaborate with biostatisticians, programmers, and cross-functional teams to resolve programming discrepancies
  • Maintain organized and inspection-ready project documentation, validation records, and quality control files
  • Manage timelines and programming deliverables across multiple concurrent studies and global projects
  • Develop specifications for datasets and outputs according to sponsor and statistical requirements
  • Review:
    • Statistical Analysis Plans (SAPs)
    • Mock shells
    • Annotated CRFs
    • Programming specifications
    • SAS database designs
  • Lead and direct statistical programming teams and monitor programming progress
  • Participate in sponsor meetings, kickoff meetings, and bid defense discussions
  • Mentor junior programmers and contribute to training and skill development initiatives
  • Support development of programming tools, macros, SOPs, and process standardization initiatives
  • Serve as a technical expert for:
    • CDISC Standards
    • SDTM
    • ADaM
    • DEFINE.XML
    • Regulatory submission requirements
  • Conduct compliance reviews of CDISC deliverables and regulatory documentation
  • Participate in industry standards initiatives and provide updates on evolving regulatory requirements
  • Support operational efficiency, innovation, and process improvement activities

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 data standards
    • Statistical programming workflows
    • Regulatory submission processes
    • Clinical pharmacology studies

Experience Requirements

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

Required Technical Skills

  • Advanced SAS programming
  • CDISC implementation
  • SDTM and ADaM dataset creation
  • DEFINE.XML preparation
  • TFL generation and validation
  • Clinical trial data analysis
  • Regulatory submission support
  • Statistical reporting and quality control
  • Programming automation and macro development

Preferred Skills

  • Clinical pharmacology and early-phase study exposure
  • Leadership and project management capabilities
  • Global clinical trial programming experience
  • Cross-functional stakeholder management
  • Inspection readiness and audit support
  • SOP and standards development
  • Technical mentoring and team training expertise

Desired Competencies

  • Strong analytical and critical thinking skills
  • Excellent written and verbal communication abilities
  • Leadership and mentoring capabilities
  • Ability to manage multiple complex projects simultaneously
  • Attention to detail and quality-focused programming practices
  • Strategic problem-solving and operational decision-making skills

Travel Requirements

  • Minimal travel may be required based on project or sponsor needs

Why Join Syneos Health?

  • Opportunity to work on advanced clinical pharmacology and global clinical research projects
  • Exposure to complex regulatory submission and statistical programming activities
  • Collaborative and innovation-driven workplace culture
  • Career growth and leadership development opportunities
  • Access to global healthcare and clinical analytics initiatives
  • Opportunity to contribute to therapies that improve patient outcomes worldwide

Global Impact of Syneos Health

Over the past five years, Syneos Health has contributed to:

  • 94% of all Novel FDA Approved Drugs
  • 95% of EMA Authorized Products
  • More than 200 studies across 73,000+ sites globally
  • Support for over 675,000 clinical trial patients worldwide