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Statistical Programmer Ii

Syneos Health
Syneos Health
0-2 years
Not Disclosed
Pune, India
9 May 13, 2026
Job Description
Job Type: Full Time 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

Company Overview

Syneos Health is a fully integrated clinical research and life sciences organization that supports drug development and commercialization across global pharmaceutical and biotechnology programs. The company focuses on accelerating clinical development through data-driven insights, statistical analysis, and operational excellence.


Job Details

Category

Details

Job Title

Statistical Programmer II

Company

Syneos Health

Job ID

25107811

Location

Pune (Hybrid)

Function

Statistical Programming / Clinical Data Analysis

Employment Type

Full-Time


Role Summary

The Statistical Programmer II is responsible for supporting statistical programming activities across clinical trials, including data manipulation, analysis, and reporting. The role contributes to the development of statistical outputs that support regulatory submissions, clinical study reports, and decision-making in drug development.

This position requires collaboration with biostatisticians and cross-functional clinical teams to ensure accurate and compliant statistical deliverables.


Key Responsibilities

1. Statistical Programming & Data Analysis

  • Develop and execute statistical programs for:

    • Data manipulation

    • Statistical analysis

    • Clinical trial reporting

  • Generate analysis datasets and outputs.


2. Clinical Trial Reporting

  • Create:

    • Tables

    • Listings

    • Figures (TLFs)

  • Support production of Clinical Study Reports (CSRs).

  • Ensure accuracy of statistical outputs used for regulatory submissions.


3. Collaboration with Study Teams

  • Work closely with:

    • Biostatisticians

    • Clinical data managers

    • Cross-functional study teams

  • Translate statistical requirements into programming specifications.


4. Data Integrity & Compliance

  • Ensure compliance with:

    • ICH guidelines

    • GCP (Good Clinical Practice)

    • Regulatory requirements

  • Maintain data quality and traceability.


5. Programming Standards & Validation

  • Validate statistical programs and outputs.

  • Ensure reproducibility and accuracy of results.

  • Apply standardized programming practices.


6. Support for Regulatory Submissions

  • Contribute to datasets and outputs used in:

    • Regulatory filings

    • Clinical study reports

    • Internal decision-making


Required Qualifications

Education

  • Bachelor’s degree in:

    • Statistics

    • Mathematics

    • Computer Science

    • Or related field


Experience

  • Experience in:

    • Clinical statistical programming

    • Clinical trial data analysis

    • Regulatory submission support


Technical Skills

  • Strong proficiency in:

    • SAS (primary requirement)

    • R (preferred)

    • Data manipulation and reporting tools

  • Experience with:

    • Clinical trial datasets

    • Statistical analysis workflows


Core Competencies

  • Strong analytical thinking

  • Attention to detail and accuracy

  • Ability to work in fast-paced environments

  • Strong collaboration skills

  • Problem-solving ability


Regulatory & Compliance Knowledge

  • ICH guidelines

  • GCP (Good Clinical Practice)

  • Clinical trial regulatory standards

  • Data integrity principles


Preferred Candidate Profile

Ideal candidates typically have experience in:

  • Statistical Programming (clinical trials)

  • SAS programming for clinical research

  • TLF generation (Tables, Listings, Figures)

  • Clinical trial datasets (SDTM/ADaM exposure preferred)

  • Biostatistics collaboration

  • CRO or pharmaceutical industry experience

  • Regulatory submission support