Sr. Statistical Programmer (ADaM & TLF)
Company: Syneos Health
Location: Hyderabad, India (Hybrid)
Job ID: 25109222
Employment Type: Full-Time
Work Mode: Hybrid
Experience: 5+ Years
About the Role
Syneos Health is seeking a Sr. Statistical Programmer with strong expertise in CDISC ADaM and TLF generation to support clinical trial programming activities. The role involves developing statistical outputs, leading programming deliverables, ensuring data quality, and collaborating with Biostatistics and Clinical teams to support global clinical studies.
Key Responsibilities
Develop SAS programs to generate:
Analysis Datasets (ADaM)
Tables
Listings
Figures (TLFs)
Statistical Outputs
Create derived datasets as per Statistical Analysis Plans (SAPs) and programming specifications.
Perform validation programming and quality control checks.
Resolve discrepancies in collaboration with Biostatisticians and project teams.
Ensure compliance with SOPs, Work Instructions, and ICH Guidelines.
Maintain complete and inspection-ready project documentation.
Manage multiple programming projects and timelines simultaneously.
Develop dataset and output specifications according to sponsor and study requirements.
Anticipate and resolve programming issues proactively.
Participate in internal meetings, project discussions, and planning activities.
Act as Lead Statistical Programmer for assigned studies.
Review:
Statistical Analysis Plans (SAPs)
Mock Shells
Programming Specifications
Annotated CRFs
Database Designs
Provide technical guidance and mentorship to junior programmers.
Participate in sponsor meetings, kickoff meetings, and bid defense meetings.
Support training and knowledge-sharing initiatives within the programming team.
Required Qualifications
Education:
Bachelor's Degree in Statistics, Mathematics, Computer Science, Life Sciences, or related Scientific Discipline.
Equivalent combination of education and Statistical Programming experience may also be considered.
Experience:
Minimum 5+ years of Statistical Programming experience.
Experience in Clinical Trial Programming environment.
Strong expertise in SAS Programming.
Required Skills
SAS Programming
Statistical Programming
CDISC Standards
ADaM Dataset Development
TLF Generation
Clinical Trial Data Analysis
Validation Programming
Statistical Analysis Plans (SAP)
Clinical Research
Regulatory Compliance
Data Quality Review
Programming Specifications Development
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