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Principal Statistical Programmer(Adam & Tlf)

Syneos Health
8+ years
Not Disclosed
Hyderabad, Remote, India, India
10 May 27, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Statistical Programmer (ADAM & TLF) – Structured Job Format

Job Overview

Position: Principal Statistical Programmer (ADAM & TLF)
Company:
Syneos Health
Location: Hyderabad (Hybrid)
Job ID: 25108564
Updated: May 22, 2026
Department: Statistical Programming / Clinical Solutions
Work Mode: Hybrid


About the Company

Syneos Health is a fully integrated life sciences services organization that supports customers across the entire drug development and commercialization continuum.

Company highlights:

  • Supported 94% of novel FDA-approved drugs in the last 5 years

  • Worked on 95% of EMA-authorized products

  • Managed 200+ studies across 73,000+ global clinical sites


Role Summary

The Principal Statistical Programmer (ADAM & TLF) is a senior-level statistical programming role responsible for:

  • Leading statistical programming activities

  • Developing ADaM datasets and TLFs

  • Providing technical leadership and mentorship

  • Managing study-level programming deliverables

  • Collaborating with statisticians, sponsors, and cross-functional teams

The role requires deep expertise in Clinical SAS programming and extensive experience in ADaM and TLF development within clinical trials.


Key Responsibilities

Statistical Programming Leadership

  • Develop and maintain:

    • Statistical programming standards

    • Best practices

    • Efficient programming workflows

  • Provide technical leadership to programming teams

ADaM & TLF Development

  • Create and maintain:

    • ADaM datasets

    • TLFs (Tables, Listings, Figures)

    • ADaM specifications

  • Ensure datasets and outputs comply with sponsor and regulatory requirements

Data Quality & Validation

  • Ensure:

    • Accuracy of statistical outputs

    • Data integrity

    • Consistency across deliverables

  • Troubleshoot and resolve complex programming issues

Study & Client Management

  • Lead statistical programming activities for studies

  • Handle direct client interactions

  • Participate in sponsor discussions and project meetings

  • Support study planning and execution activities

Process Improvement

  • Design efficient programming solutions

  • Improve productivity through automation and optimization

  • Contribute to continuous improvement initiatives

Code Review & Mentorship

  • Conduct code reviews

  • Provide constructive technical feedback

  • Mentor and train junior programmers and team members

Collaboration & Communication

  • Work closely with:

    • Statisticians

    • Clinical teams

    • Data management teams

    • Sponsors

  • Translate programming requirements into technical solutions

Innovation & Technical Development

  • Stay updated on:

    • SAS advancements

    • Statistical programming technologies

    • Industry standards

  • Introduce relevant programming techniques and tools


Required Qualifications

Experience

  • Minimum 8+ years of experience in:

    • Clinical SAS

    • Base SAS

    • Advanced SAS

Core Expertise

  • Strong hands-on experience in:

    • ADaM programming

    • TLF programming

    • ADaM specifications

    • Dataset generation

Additional Preferred Experience

  • ISS/ISE or pooled study experience

  • Safety and efficacy data programming

  • Study leadership and client handling experience


Technical Skills

Programming Languages & Tools

  • SAS (mandatory)

  • R (preferred)

  • Python (preferred)

Domain Knowledge

  • Clinical trial data standards

  • Statistical analysis workflows

  • Regulatory submission requirements

  • Data validation and QC processes

Specialized Skills

  • ADaM dataset creation

  • TLF generation

  • Statistical programming process optimization

  • Cross-study pooling and integration


Certifications

Preferred:

  • SAS Certified Advanced Programmer for SAS 9
    OR

  • Equivalent SAS certification


Soft Skills

  • Strong communication and interpersonal skills

  • Leadership and mentoring capabilities

  • Analytical and problem-solving mindset

  • Ability to work independently and collaboratively

  • Strong stakeholder management skills


Preferred Competencies

  • Sponsor-facing experience

  • Leading end-to-end studies

  • Regulatory submission support

  • Inspection readiness

  • Team management or project leadership experience


Work Environment & Culture

Why Join Syneos Health?

  • Strong career development programs

  • Technical and therapeutic-area training

  • Collaborative global work environment

  • Inclusive and diverse culture

  • Recognition and rewards programs

  • Exposure to global clinical research projects


Functional Areas Covered

  • Statistical Programming

  • ADaM Development

  • TLF Programming

  • Clinical SAS

  • Clinical Trial Analytics

  • Regulatory Data Reporting


Seniority & Impact

This is a senior-level individual contributor role with:

  • Cross-functional influence

  • Study leadership responsibilities

  • Mentorship and review responsibilities

  • Strategic contributions to programming standards and processes

The role contributes directly to:

  • Clinical study success

  • Programming efficiency

  • Data quality and regulatory compliance


Ideal Candidate Profile

The ideal candidate should:

  • Have deep expertise in ADaM and TLF programming

  • Be highly proficient in SAS programming

  • Demonstrate strong study leadership capabilities

  • Be comfortable handling sponsors and clients directly

  • Mentor and guide junior programmers effectively

  • Thrive in a collaborative, fast-paced environment


Employment Notes

  • Additional responsibilities may be assigned as needed

  • Equivalent qualifications and experience may be considered

  • Syneos Health is an equal opportunity employer

  • Reasonable accommodations are available where appropriate


Application

Apply via:
Syneos Health Careers