Sr Statistical Programmer (ADaM & TLF) – Syneos Health
Company: Syneos Health
Job Title: Senior Statistical Programmer (ADaM & TLF)
Job ID: 25109222
Location: Hyderabad, India (Hybrid)
Experience: 5+ Years
Function: Biostatistics & Statistical Programming
Industry: Clinical Research / CRO / Pharmaceutical Development
Role Overview
The Senior Statistical Programmer is a highly specialized clinical development role responsible for transforming clinical trial data into regulatory-compliant analysis datasets, tables, listings, and figures used for statistical analysis and regulatory submissions.
This position sits at the intersection of:
Clinical Data Management
Biostatistics
Statistical Programming
Regulatory Submissions
Clinical Trial Reporting
The role supports clinical studies from database lock through analysis and submission activities and often serves as the lead programmer on projects.
Primary Responsibilities
Statistical Programming
Develop SAS programs to:
Create analysis datasets
Generate Tables, Listings, and Figures (TLFs)
Produce statistical outputs
Support clinical study reporting
Key deliverables include:
Analysis-ready datasets
Regulatory submission outputs
Statistical reports
Study-level programming deliverables
CDISC ADaM Development
Strong expertise required in:
CDISC ADaM
Responsibilities include:
Creating ADaM datasets from SDTM data
Defining derived variables
Implementing analysis specifications
Ensuring CDISC compliance
Typical datasets:
ADSL
ADAE
ADLB
ADVS
ADTTE
Other analysis datasets
TLF Generation
Develop:
Tables
Listings
Figures
according to:
Statistical Analysis Plans (SAPs)
Programming Specifications
Sponsor Requirements
Examples:
Demographic summaries
Safety tables
Efficacy analyses
Adverse event listings
Laboratory summaries
Survival analyses
Validation & Quality Control
Perform independent validation programming.
Verify datasets and outputs.
Resolve discrepancies with biostatistics teams.
Ensure inspection-ready deliverables.
Documentation & Compliance
Maintain:
Programming specifications
Validation documents
QC documentation
Review comments
Regulatory records
Ensure compliance with:
International Council for Harmonisation guidelines
Sponsor SOPs
Regulatory requirements
Internal quality standards
Project Leadership
As a Senior Programmer, responsibilities include:
Leading programming activities
Reviewing junior programmers' work
Monitoring timelines
Managing study deliverables
Supporting project planning
Stakeholder Collaboration
Work closely with:
Biostatisticians
Clinical Data Managers
Medical Writers
Project Managers
Clinical Scientists
Sponsors
Participate in:
Kickoff meetings
Sponsor meetings
Bid defense meetings
Mentoring & Training
Train junior programmers.
Review deliverables.
Conduct knowledge-sharing sessions.
Support capability development within the team.
Required Qualifications
Education
Preferred:
Bachelor's Degree in:
Statistics
Mathematics
Life Sciences
Computer Science
Biostatistics
Scientific disciplines
Equivalent experience may also be considered.
Experience Requirements
Mandatory
5+ years of SAS Programming experience.
Clinical trial programming experience.
Pharmaceutical, biotech, or CRO background.
Uttar Pradesh :
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