Senior Statistical Programmer
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104350
Employment Type: Full-Time
Job Overview
Syneos Health®, a globally recognized biopharmaceutical solutions organization, is seeking a Senior Statistical Programmer to support clinical development programs through high-quality statistical programming deliverables. This role involves leading programming activities for clinical trials, developing complex datasets and outputs, ensuring regulatory compliance, and mentoring programming teams across multiple studies.
The position requires strong expertise in SAS programming, deep understanding of clinical trial data standards, and the ability to manage concurrent projects in a regulated environment.
Key Responsibilities
Develop and validate statistical programming code using SAS or equivalent software to generate analysis datasets, tables, listings, and figures in accordance with Statistical Analysis Plans (SAPs) and programming specifications
Ensure programming outputs meet quality, regulatory, and project-specific standards
Perform independent validation programming and resolve discrepancies in collaboration with biostatisticians and cross-functional teams
Maintain compliance with applicable SOPs, Work Instructions (WIs), ICH guidelines, and regulatory requirements
Create and maintain complete, inspection-ready programming documentation, including QC and validation records
Manage workload across multiple projects, adapting to changing timelines and priorities while ensuring on-time delivery
Develop and review dataset and output specifications of moderate to high complexity, anticipating programming challenges and minimizing rework
Actively participate in internal project meetings, providing technical input and status updates
Lead internal programming discussions, ensuring clear communication, accurate documentation, and timely follow-up on action items
Estimate timelines accurately and deliver programming milestones within agreed schedules
Serve as Lead Statistical Programmer on assigned studies, directing and reviewing the work of junior programmers
Review key project documentation including SAPs, mock shells, annotated CRFs, and database designs, providing feedback to improve efficiency and quality
Represent statistical programming in sponsor meetings, study kickoffs, and bid defense discussions when required
Mentor and support programming team members through training, work review, and process guidance
Support knowledge sharing and continuous improvement initiatives within the statistical programming function
Perform additional responsibilities as assigned; minimal travel may be required
Education and Experience Requirements
Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline
6–10+ years of hands-on statistical programming experience, preferably within a clinical trials or CRO environment
Extensive experience with SAS programming for clinical trial data analysis
Demonstrated ability to lead study-level programming activities and mentor junior programmers
Strong understanding of clinical trial processes and regulatory expectations
Technical and Professional Skills
Advanced proficiency in SAS programming for TFLs and analysis datasets
Strong knowledge of clinical trial documentation and statistical workflows
Familiarity with regulatory standards such as ICH guidelines
Excellent written and verbal communication skills in English
Strong organizational skills with the ability to manage multiple deliverables simultaneously
Proven ability to work collaboratively in cross-functional, global teams
About Syneos Health
Syneos Health® operates in more than 110 countries and has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products in the past five years. The organization has delivered over 200 clinical studies across 73,000 global sites, accelerating the development of innovative therapies worldwide.
Additional Information
Responsibilities may evolve based on business needs
Equivalent education and relevant experience will be considered
This job description does not constitute an employment contract
Syneos Health is an equal opportunity employer and complies with all applicable employment regulations
SEO & Search Optimization Keywords
Senior Statistical Programmer Jobs, SAS Programmer Clinical Trials, Biostatistics Programming Jobs India, CRO Statistical Programmer, Clinical SAS Jobs Pune, Statistical Programming Careers, Pharma Data Programming Roles
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