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Sr Stat / Principal Statistical Programmer

Syneos Health
Syneos Health
5+ years
Not Disclosed
Remote, India, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr Stat / Principal Statistical Programmer (PKPD Programming) – Clinical Data & Pharmacokinetic Analysis

Company: Syneos Health
Job Title: Sr Stat / Pr Stat Programmer (PKPD Programming)
Location: Remote – India
Job ID: 25107313
Department: Clinical Solutions / Statistical Programming


About the Role

Syneos Health is hiring a Sr Stat / Principal Statistical Programmer (PKPD Programming) for its global clinical research and biostatistics team. This remote opportunity is ideal for professionals experienced in Statistical Programming, PKPD Analysis, Clinical Data Programming, CDISC Standards, and Pharmacokinetic Data Analysis.

The selected candidate will support pharmacokinetic and pharmacodynamic (PKPD) programming activities, clinical data analysis, dataset generation, statistical outputs, and regulatory-compliant reporting for global clinical studies.

This opportunity is best suited for professionals with strong expertise in R Programming, SAS Programming, CDISC standards, PK workflows, and NONMEM datasets.


Key Responsibilities

Statistical Programming & Clinical Data Analysis

  • Develop custom programming code using:
    • SAS
    • R
    • Other statistical programming tools
  • Generate:
    • Summary tables
    • Data listings
    • Graphs and figures
    • Derived datasets
  • Support outputs as defined in:
    • Statistical Analysis Plans (SAP)
    • Programming specifications
  • Ensure programming deliverables meet quality and regulatory standards

PKPD & Pharmacokinetic Programming

  • Develop and validate PK analysis datasets including:
    • ADPC
    • ADNCA
    • ADPP
  • Generate tables, listings, and figures (TLFs) for PK analysis and reporting
  • Work on:
    • NONMEM datasets
    • NCA datasets
    • PK workflows across multiple study designs
  • Serve as Subject Matter Expert (SME) for PK analysis programming

Validation & Quality Control

  • Perform validation programming and quality control activities
  • Resolve discrepancies in collaboration with:
    • Biostatisticians
    • Clinical Pharmacologists
    • Study Lead Programmers
  • Maintain:
    • Inspection-ready documentation
    • Testing and verification records
    • Quality control documentation

Project Management & Collaboration

  • Manage timelines and programming deliverables across multiple projects
  • Participate in:
    • Sponsor meetings
    • Kickoff meetings
    • Bid defense meetings
  • Collaborate with:
    • Clinical Pharmacologists
    • Statisticians
    • Cross-functional clinical teams
  • Translate analysis requirements into effective programming solutions

Leadership & Mentorship

  • Act as Lead Statistical Programmer on assigned projects
  • Guide and review work of programming team members
  • Review:
    • Statistical Analysis Plans
    • Mock shells
    • Programming specifications
    • Annotated CRFs
    • SAS database designs
  • Mentor junior programmers and support training initiatives

Regulatory Compliance & Documentation

  • Ensure compliance with:
    • ICH Guidelines
    • CDISC Standards
    • SOPs and Work Instructions
  • Maintain complete and up-to-date project documentation
  • Ensure inspection readiness and regulatory compliance for programming deliverables

Educational Qualification

Candidates should possess:

  • B.Sc. or equivalent degree in:
    • Mathematics
    • Statistics
    • Computer Science
    • Related quantitative or scientific discipline

Required Experience

  • 5+ years of experience in:
    • Clinical Statistical Programming
    • PKPD Programming
    • Clinical Data Analysis
    • Pharmacokinetic Programming
    • Biostatistics support

Preferred Experience Areas

  • Clinical trials programming
  • PK analysis workflows
  • NONMEM and NCA datasets
  • CDISC implementation
  • Sponsor-facing programming activities