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Principal Statistical Programmer – Clinical Sas Programming & Cdisc Compliance

Syneos Health
Syneos Health
8+ years
preferred by company
Remote, India, India
1 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: mRS and EQ-5D-5L., Narrative Writing, Research & Development

Principal Statistical Programmer – Clinical SAS Programming & CDISC Compliance

Company: Syneos Health
Job Title: Pr Statistical Programmer
Location: Remote – India
Job ID: 25107317
Department: Clinical Solutions / Statistical Programming


About the Role

Syneos Health is hiring a Principal Statistical Programmer for its global Biostatistics and Statistical Programming team. This remote opportunity is ideal for professionals experienced in Clinical SAS Programming, CDISC Standards, ADaM Programming, SDTM Implementation, and Regulatory Submission Support.

The selected candidate will lead statistical programming activities across clinical studies, support regulatory submissions, manage programming deliverables, and collaborate with global biostatistics and clinical research teams.

This role is best suited for candidates with extensive experience in Clinical SAS Programming, TLF generation, submission package creation, and CDISC compliance.


Key Responsibilities

Clinical SAS Programming & Statistical Analysis

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

CDISC & Regulatory Submission Support

  • Develop and review:
    • SDTM datasets
    • ADaM datasets
    • TLFs (Tables, Listings & Figures)
  • Support creation of submission packages including:
    • ADRG
    • define.xml
  • Perform compliance reviews for:
    • CDISC deliverables
    • Regulatory submission datasets
    • Define documentation
  • Provide guidance on CDISC standards and industry regulatory requirements

Validation, Quality Control & Documentation

  • Perform validation programming and discrepancy resolution
  • Collaborate with:
    • Biostatisticians
    • Statistical programmers
    • Clinical project teams
  • Maintain:
    • Inspection-ready documentation
    • Quality control records
    • Testing and verification documentation
  • Ensure compliance with:
    • ICH Guidelines
    • SOPs
    • Work Instructions (WIs)

Leadership & Team Management

  • Act as Lead Statistical Programmer on assigned projects
  • Direct and monitor programming activities of team members
  • Review:
    • Statistical Analysis Plans
    • Mock shells
    • Annotated CRFs
    • Programming specifications
    • SAS database designs
  • Mentor junior programmers and support training initiatives
  • Develop training materials and provide technical guidance

Project & Stakeholder Management

  • Manage concurrent programming deliverables and project timelines
  • Provide risk mitigation strategies for project delays or issues
  • Participate in:
    • Sponsor meetings
    • Kickoff meetings
    • Bid defense meetings
  • Communicate project status and deliverable updates to stakeholders

Process Improvement & Technical Expertise

  • Support development of:
    • SOPs
    • Programming guidelines
    • Standardized tools and macros
  • Serve as Subject Matter Expert (SME) for:
    • CDISC standards
    • Regulatory programming requirements
    • Submission compliance
  • Participate in industry standards initiatives and regulatory updates

Educational Qualification

Candidates should possess:

  • Undergraduate Degree in:
    • Statistics
    • Mathematics
    • Computer Science
    • Life Sciences
    • Scientific or quantitative disciplines

OR equivalent combination of education and demonstrated programming experience.


Required Experience

  • Minimum 8+ years of Clinical SAS Programming experience

Mandatory Experience Areas

  • ADaM Programming
  • SDTM Implementation
  • TLF Programming (Safety & Efficacy Outputs)
  • Regulatory Submission Package Creation
  • ADRG & define.xml preparation
  • Clinical trial data programming