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Principal Statistical Programmer (Adam, Tlf & Sdtm)

Syneos Health
Syneos Health
8+ years
preferred by company
Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: 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, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

 

Principal Statistical Programmer (ADaM, TLF & SDTM) – Remote Clinical SAS Programming Jobs in India | Syneos Health

Location: Remote, India
Company: Syneos Health
Job Type: Full-Time
Work Mode: Remote
Department: Biostatistics / Statistical Programming / Biometrics
Experience Required: 8+ years of Clinical SAS Programming experience
Job ID: 25107309


About the Company

Syneos Health is a globally recognized clinical research and biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and healthcare innovators throughout the drug development lifecycle. With deep expertise in clinical development, biometrics, regulatory operations, and medical research, the company offers high-impact opportunities for experienced data science and statistical programming professionals.

This role is ideal for senior professionals seeking leadership opportunities in clinical SAS programming, ADaM dataset development, SDTM implementation, TLF generation, oncology programming, CDISC compliance, and regulatory submission programming.


Job Overview

Syneos Health is hiring a Principal Statistical Programmer (ADaM, TLF & SDTM) for a remote India-based opportunity. This senior leadership role is designed for highly experienced statistical programming professionals with strong expertise in Clinical SAS programming, oncology clinical trials, regulatory programming, safety and efficacy outputs, CDISC implementation, ISS/ISE submissions, and advanced programming leadership.

The selected candidate will lead complex programming initiatives, provide technical guidance across multiple studies, mentor programming teams, support sponsor interactions, and drive regulatory-compliant statistical programming deliverables for global clinical development programs.

This is an excellent opportunity for experienced biometrics professionals seeking senior-level CRO leadership roles.


Key Responsibilities

Clinical SAS Programming & Statistical Deliverables

  • Develop advanced programming solutions using Base SAS, SAS Macros, R programming, and statistical programming tools.
  • Generate high-quality Tables, Listings, and Figures (TLFs) and derived analysis datasets based on statistical analysis plans and sponsor specifications.
  • Develop programming code for complex clinical trial analyses across multiple therapeutic programs.
  • Ensure all deliverables meet regulatory, sponsor, and quality standards.

ADaM, SDTM & CDISC Programming

  • Lead ADaM dataset programming, SDTM implementation, and CDISC-compliant deliverables.
  • Review annotated CRFs, mock shells, statistical specifications, and dataset design documentation.
  • Provide subject matter expertise for:
    • ADaM
    • SDTM
    • DEFINE.XML
    • CDISC standards
    • Electronic regulatory submissions
  • Conduct CDISC compliance reviews and programming quality assessments.

Safety, Efficacy & Regulatory Programming

  • Support both safety and efficacy statistical outputs.
  • Contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) deliverables.
  • Support regulatory submission-ready clinical programming packages.
  • Maintain inspection-ready validation, testing, and QC documentation.

Project Leadership & Delivery Management

  • Lead programming activities across multiple concurrent global studies.
  • Manage timelines, delivery risks, workload prioritization, and stakeholder expectations.
  • Develop mitigation plans for programming risks and delivery constraints.
  • Ensure on-time delivery of programming milestones.

Technical Leadership & Team Mentorship

  • Act as lead statistical programmer and technical escalation point.
  • Guide junior and senior programming staff across study execution.
  • Conduct programming reviews, technical coaching, and training sessions.
  • Develop reusable programming tools, macros, and process efficiencies.

Sponsor & Cross-Functional Collaboration

  • Represent statistical programming in:
    • Sponsor meetings
    • Study kickoff meetings
    • Bid defense discussions
    • Internal biometrics planning meetings
  • Collaborate with:
    • Biostatisticians
    • Clinical data management teams
    • Regulatory teams
    • Clinical operations stakeholders
    • Sponsor representatives

Industry Standards & Subject Matter Expertise

  • Serve as technical SME for CDISC and industry programming standards.
  • Guide internal teams on regulatory changes and standards implementation.
  • Participate in standards governance and knowledge-sharing initiatives.
  • Support SOP, guideline, and internal process development.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Statistics
    • Biostatistics
    • Mathematics
    • Computer Science
    • Data Science
    • Life Sciences
    • Related quantitative disciplines
  • Minimum 8+ years of Clinical SAS Programming experience
  • Strong expertise in:
    • Base SAS
    • SAS Macros
    • SDTM
    • ADaM
    • TLF programming
    • Specs creation
    • Clinical trial reporting
  • Hands-on experience with:
    • Safety outputs
    • Efficacy outputs
    • ISS / ISE programming
    • Oncology clinical studies
    • Regulatory submissions
    • R programming
  • Strong understanding of:
    • CDISC standards
    • DEFINE.XML
    • ICH guidelines
    • Clinical trial programming lifecycle
    • Electronic submission standards