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Statistical Programmer Ii

Syneos Health
Syneos Health
3-6 years
preferred by company
Hyderabad
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Job Title: Statistical Programmer II

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

About the Role
We are seeking a highly analytical and technically proficient Statistical Programmer II to support global clinical development programs through advanced statistical programming, regulatory reporting, clinical data analysis, and biometrics operations. 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 collaborate with biostatistics, clinical data management, and cross-functional clinical teams to deliver high-quality statistical programming outputs that support global clinical trials, regulatory submissions, and evidence-based decision-making.

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

Key Responsibilities

Statistical Programming & Clinical Data Deliverables

  • Develop, validate, and maintain high-quality statistical programming deliverables for clinical research studies.
  • Generate and validate Tables, Listings, and Figures (TLFs) for interim analyses, final study reporting, and regulatory documentation.
  • Support creation of analysis-ready datasets and programming outputs aligned with statistical analysis requirements.
  • Ensure programming deliverables meet quality, timeline, and compliance expectations.

CDISC Standards & Dataset Programming

  • Design, transform, and validate clinical datasets using CDISC standards, including:
    • SDTM (Study Data Tabulation Model)
    • ADaM (Analysis Data Model)
  • Support metadata mapping, dataset conversion, programming validation, and submission-readiness checks.
  • Maintain consistency with global data standards and regulatory expectations.

Regulatory Submission Support

  • Contribute to preparation of statistical programming deliverables supporting submissions to FDA, EMA, PMDA, and other global health authorities.
  • Ensure regulatory-compliant documentation, validation traceability, and audit-ready programming workflows.
  • Support compliance with internal SOPs, client expectations, and submission standards.

Biostatistics Collaboration & Analysis Support

  • Work closely with Biostatisticians, Clinical Data Managers, Medical Writers, and Clinical Operations teams to translate study requirements into programming deliverables.
  • Interpret Statistical Analysis Plans (SAPs) and convert specifications into validated code and reporting outputs.
  • Support statistical result generation and data-driven study reporting activities.

Programming Validation & Quality Control

  • Perform code review, validation, debugging, reconciliation, and quality control checks for statistical outputs.
  • Troubleshoot programming issues, data inconsistencies, and reporting discrepancies efficiently.
  • Maintain high standards of programming accuracy and documentation quality.

Clinical Trial Data Standards & Compliance

  • Ensure alignment with ICH-GCP, CDISC standards, clinical trial regulatory frameworks, and biometrics best practices.
  • Support standardized programming methodologies, reusable macros, and process efficiency improvements.
  • Maintain awareness of evolving statistical programming and regulatory expectations.

Cross-Functional Project Support

  • Participate in project meetings, biometrics planning sessions, study discussions, and stakeholder coordination activities.
  • Support deliverable tracking, issue escalation, timeline adherence, and collaborative global execution.
  • Adapt effectively in fast-paced, dynamic global project environments.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Statistics
    • Biostatistics
    • Mathematics
    • Computer Science
    • Data Science
    • Life Sciences
    • Biotechnology
    • Related quantitative disciplines
  • Minimum 3–6 years of relevant experience in statistical programming within CRO, pharmaceutical, biotechnology, or clinical research organizations.
  • Strong hands-on expertise in:
    • SAS programming
    • CDISC implementation
    • SDTM programming
    • ADaM dataset creation
    • TLF generation
    • Clinical trial statistical programming
  • Experience supporting clinical reporting and regulatory programming deliverables.
  • Strong analytical reasoning, debugging, programming logic, and problem-solving capabilities.
  • Good understanding of biometrics workflows, clinical trial data structures, and clinical development processes.
  • Excellent written and verbal communication skills.
  • Ability to collaborate effectively with global teams in hybrid work environments.