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Sr Statistical Programmer

Syneos Health
2+ years
Not Disclosed
Remote, India, India
10 May 27, 2026
Job Description
Job Type: Full Time Hybrid Remote 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

Sr Statistical Programmer – Structured Job Format

Job Overview

Position: Sr Statistical Programmer
Company:
Syneos Health
Location: IND-Remote
Job ID: 25107604
Updated: May 25, 2026
Department: Statistical Programming / Clinical Solutions
Work Mode: Remote


About the Company

Syneos Health is a leading fully integrated life sciences organization supporting drug development and commercialization across global healthcare markets.

The company has contributed to:

  • 94% of novel FDA-approved drugs in the past 5 years

  • 95% of EMA-authorized products

  • 200+ studies across 73,000+ clinical sites worldwide


Role Summary

The Sr Statistical Programmer is responsible for:

  • Developing statistical programming deliverables for clinical trials

  • Creating analysis datasets, tables, listings, and graphs

  • Supporting biostatistics and clinical study teams

  • Ensuring data quality, regulatory compliance, and inspection readiness

  • Leading programming activities and mentoring junior programmers

The role requires strong expertise in SAS programming within a clinical trial environment.


Key Responsibilities

Statistical Programming

  • Develop custom SAS programs and scripts

  • Generate:

    • Summary tables

    • Data listings

    • Statistical graphs

    • Derived datasets

  • Program outputs according to:

    • Statistical Analysis Plans (SAP)

    • Programming specifications

    • Sponsor requirements

Validation & Quality Control

  • Perform validation programming

  • Conduct QC checks for datasets and outputs

  • Resolve discrepancies with:

    • Programmers

    • Biostatisticians

    • Project teams

  • Ensure outputs meet quality and compliance standards

Documentation & Compliance

  • Maintain:

    • Programming documentation

    • Testing records

    • Verification and QC documents

  • Ensure inspection readiness

  • Follow:

    • SOPs

    • Work Instructions (WIs)

    • ICH and regulatory guidelines

Project & Time Management

  • Manage multiple projects simultaneously

  • Handle competing priorities and deadlines

  • Provide accurate effort estimates

  • Adapt workloads based on project timelines

Dataset & Specification Development

  • Create programming specifications

  • Design complex datasets and outputs

  • Define variables accurately for peer and sponsor review

  • Anticipate and resolve programming challenges proactively

Team Collaboration

  • Participate in:

    • Internal meetings

    • Sponsor meetings

    • Kickoff meetings

    • Bid defense meetings

  • Share project updates and programming progress

  • Collaborate cross-functionally with project teams

Leadership Responsibilities

  • Act as Lead Statistical Programmer on assigned projects

  • Oversee programming deliverables

  • Guide and review work of junior programmers

  • Mentor team members through:

    • Training sessions

    • Feedback

    • Work reviews

Study Documentation Review

  • Review:

    • Statistical Analysis Plans (SAP)

    • Mock shells

    • Programming specifications

    • Annotated CRFs

    • SAS database design

  • Provide process improvement recommendations


Required Qualifications

Education

  • Undergraduate degree in:

    • Scientific discipline

    • Statistical discipline
      OR

  • Equivalent combination of education and programming experience


Required Skills & Experience

Technical Skills

  • Extensive SAS programming experience

  • Strong understanding of:

    • Clinical trial data

    • Statistical programming processes

    • Regulatory standards

  • Experience creating:

    • Analysis datasets

    • Tables

    • Listings

    • Figures (TLFs)

Industry Experience

  • Preferably from a clinical trial or CRO environment

Soft Skills

  • Excellent written and verbal communication

  • Strong analytical and problem-solving skills

  • Time management and organizational skills

  • Ability to collaborate effectively in cross-functional teams

Language

  • Ability to read, write, speak, and understand English


Travel Requirements

  • Minimal travel may be required


Preferred Competencies

  • Leadership and mentoring experience

  • Knowledge of CDISC standards (SDTM/ADaM preferred)

  • Strong documentation and QC practices

  • Ability to manage end-to-end programming activities

  • Inspection/audit readiness support experience


Work Environment & Culture

Why Join Syneos Health?

  • Career growth and advancement opportunities

  • Technical and therapeutic-area training

  • Collaborative global work environment

  • Inclusive and diverse workplace culture

  • Recognition and rewards programs

  • Exposure to global clinical research projects


Functional Areas Covered

  • Statistical Programming

  • Clinical Trial Analytics

  • SAS Programming

  • Data Validation

  • Regulatory Compliance

  • Clinical Data Reporting


Ideal Candidate Profile

The ideal candidate should:

  • Have strong SAS programming expertise

  • Understand clinical trial data structures deeply

  • Be capable of independently managing complex programming tasks

  • Demonstrate leadership and mentoring abilities

  • Work effectively in remote and cross-functional environments

  • Maintain high attention to detail and quality standards


Employment Notes

  • Additional duties may be assigned as needed

  • Equivalent qualifications and experience may be considered

  • Syneos Health is an equal opportunity employer

  • Reasonable accommodations are available where applicable


Application

Apply via:
Syneos Health Careers