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Senior Statistical Programmer (Adam, Tlf & Sdtm)

Syneos Health
Syneos Health
5+ years
preferred by company
Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, 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

Senior 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 / Clinical Data Sciences
Experience Required: 5+ years of Clinical SAS Programming experience
Job ID: 25107308


About the Company

Syneos Health is a globally recognized biopharmaceutical solutions and clinical research organization supporting pharmaceutical, biotechnology, and healthcare innovators across the full drug development lifecycle. The organization delivers specialized expertise in clinical development, biostatistics, regulatory operations, pharmacovigilance, and medical communications.

This opportunity is ideal for experienced professionals seeking advanced careers in clinical SAS programming, statistical programming, ADaM dataset development, SDTM programming, TLF generation, and regulatory clinical data reporting.


Job Overview

Syneos Health is hiring a Senior Statistical Programmer (ADaM, TLF & SDTM) for a remote India-based opportunity. This role is designed for experienced statistical programming professionals with strong expertise in Clinical SAS programming, CDISC standards, ADaM dataset creation, SDTM implementation, TLF generation, and regulatory submission support.

The selected candidate will lead statistical programming activities across clinical studies, collaborate with biostatistics and clinical teams, oversee programming deliverables, perform quality validation, mentor junior programmers, and support sponsor-facing programming operations.

This is an excellent opportunity for professionals seeking senior-level remote CRO careers in clinical data sciences and regulatory statistical programming.


Key Responsibilities

Clinical SAS Programming

  • Develop custom programming solutions using Base SAS, SAS Macros, and clinical statistical programming tools.
  • Generate summary tables, listings, figures (TLFs), and derived analysis datasets according to statistical analysis plans and programming specifications.
  • Create robust programming code for clinical trial data analysis and reporting.

ADaM & SDTM Dataset Programming

  • Develop and validate ADaM datasets based on CDISC standards.
  • Support SDTM dataset programming, mapping, and implementation for clinical trial submissions.
  • Create dataset specifications aligned with sponsor and regulatory requirements.
  • Review annotated CRFs, mock shells, and statistical documentation for programming readiness.

Validation & Quality Control

  • Perform independent validation programming and quality control checks.
  • Resolve discrepancies in outputs through collaboration with biostatistics and project teams.
  • Maintain inspection-ready programming documentation, testing records, and verification evidence.
  • Ensure compliance with regulatory expectations and internal SOPs.

Project Leadership & Delivery Management

  • Lead programming activities across multiple concurrent clinical studies.
  • Manage timelines, resource allocation, and programming priorities.
  • Anticipate technical programming challenges and proactively develop solutions.
  • Deliver programming outputs within agreed timelines and quality expectations.

Team Leadership & Mentorship

  • Act as the lead statistical programmer for assigned studies.
  • Guide and monitor junior and mid-level programming team members.
  • Review programming deliverables and provide technical feedback.
  • Support internal training, mentoring, and capability development.

Cross-Functional Collaboration

  • Work closely with:
    • Biostatisticians
    • Clinical data management teams
    • Regulatory stakeholders
    • Clinical operations teams
    • Sponsor representatives
  • Participate in sponsor meetings, kickoff discussions, and bid defense meetings as required.
  • Contribute to project planning, internal reviews, and operational decision-making.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Statistics
    • Biostatistics
    • Mathematics
    • Computer Science
    • Life Sciences
    • Data Science
    • Related quantitative disciplines
  • Minimum 5+ years of experience in Clinical SAS Programming
  • Strong hands-on expertise in:
    • Base SAS
    • SAS Macros
    • ADaM programming
    • SDTM implementation
    • TLF generation
    • Clinical trial programming
  • Strong understanding of:
    • CDISC standards
    • Statistical Analysis Plans (SAP)
    • Annotated CRFs
    • Regulatory clinical submissions
    • ICH guidelines
    • Clinical trial data structures