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Statistical Programmer Ii

Syneos Health
Syneos Health
3-6 years
preferred by company
Pune, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Job Title: Statistical Programmer II

Location: Pune, Maharashtra, India (Hybrid)
Job Type: Full-Time
Experience Required: 3–6 Years (Freshers are not eligible)
Industry: Biostatistics / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
Department: Biometrics / Statistical Programming / Clinical Data Sciences

About the Role
We are seeking a highly analytical and technically skilled Statistical Programmer II to support global clinical development programs through advanced statistical programming, clinical data analysis, regulatory reporting, and biometrics deliverables. This opportunity is ideal for professionals with expertise in SAS programming, CDISC standards, SDTM, ADaM, TLF generation, clinical trial data analysis, and regulatory statistical programming.

The ideal candidate will work closely with biostatistics, clinical data management, and clinical operations teams to deliver high-quality statistical programming outputs that support clinical trial decision-making and regulatory submissions.

This role is well suited for experienced statistical programmers seeking growth in global CRO and pharmaceutical clinical development environments.

Key Responsibilities

Statistical Programming & Clinical Data Analysis

  • Develop, validate, and maintain statistical programming deliverables for clinical research studies.
  • Generate Tables, Listings, and Figures (TLFs) for clinical trial analysis, interim reporting, and final study reporting.
  • Support analysis dataset preparation, clinical data transformation, and statistical reporting workflows.
  • Ensure high-quality programming outputs aligned with protocol requirements and analysis specifications.

CDISC Standards & Clinical Dataset Development

  • Create and maintain clinical datasets compliant with CDISC standards, including:
    • SDTM (Study Data Tabulation Model)
    • ADaM (Analysis Data Model)
  • Support dataset mapping, transformation logic, metadata consistency, and validation checks.
  • Ensure regulatory-compliant dataset preparation for submission readiness.

Regulatory Reporting & Submission Support

  • Support preparation of statistical deliverables for regulatory submissions to agencies such as FDA, EMA, PMDA, and global health authorities.
  • Ensure programming documentation, datasets, outputs, and validation processes meet compliance expectations.
  • Maintain audit-ready statistical programming documentation and traceability.

Biostatistics Collaboration & Analysis Support

  • Collaborate closely with Biostatisticians, Clinical Data Managers, Medical Writers, and Clinical Operations teams to understand study analysis requirements.
  • Translate Statistical Analysis Plan (SAP) requirements into executable programming solutions.
  • Support interpretation and implementation of statistical analysis methodologies.

Programming Quality Control & Validation

  • Perform programming quality checks, independent validation, debugging, and issue resolution.
  • Ensure programming deliverables meet internal SOPs, quality standards, and client expectations.
  • Troubleshoot data inconsistencies, output issues, and programming errors efficiently.

Clinical Data Standards & Process Compliance

  • Maintain understanding of ICH-GCP, CDISC, GCP, clinical trial regulations, and internal programming standards.
  • Ensure consistency across data handling, validation logic, and statistical reporting processes.
  • Support standardization and reusable programming framework initiatives.

Cross-Functional Project Support

  • Participate in project meetings, biometrics discussions, study planning sessions, and stakeholder interactions.
  • Support timeline adherence, deliverable tracking, and issue escalation where required.
  • Collaborate across global teams in hybrid clinical development environments.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Statistics
    • Biostatistics
    • Mathematics
    • Computer Science
    • Life Sciences
    • Biotechnology
    • Data Science
    • Related quantitative disciplines
  • Minimum 3–6 years of relevant experience in statistical programming within CRO, pharmaceutical, or clinical research environments.
  • Strong hands-on expertise in:
    • SAS programming
    • CDISC standards
    • SDTM
    • ADaM
    • TLF generation
    • Clinical trial data programming
  • Experience supporting clinical study reporting and regulatory deliverables.
  • Strong analytical thinking, programming logic, debugging, and problem-solving capabilities.
  • Good understanding of clinical trial workflows and biometrics operations.
  • Strong written and verbal communication skills.
  • Ability to work effectively in collaborative, fast-paced project environments.