Senior / Principal Statistical Programmer (R / R Shiny)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25103962
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success. By integrating clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that address today’s complex healthcare challenges.
With operations across 110+ countries and a workforce of over 29,000 professionals, Syneos Health places patients and customers at the center of everything it does. The organization fosters agility, innovation, and collaboration to accelerate the delivery of life-changing therapies worldwide.
Job Summary
The Senior / Principal Statistical Programmer (R / R Shiny) plays a critical role in delivering high-quality statistical programming solutions for clinical trials. This role involves end-to-end development of analysis datasets, tables, listings, figures, and interactive visualizations using R, R Shiny, SAS, or related tools, while ensuring regulatory compliance and inspection readiness.
The position may operate as a senior individual contributor or as a lead programmer, guiding teams, managing complex deliverables, and supporting sponsors throughout the clinical development lifecycle.
Key Responsibilities
Develop, validate, and maintain statistical programming code using R, R Shiny, SAS, or equivalent tools to generate analysis datasets, summary tables, listings, figures, and visualizations per SAPs and programming specifications.
Ensure programming outputs meet internal quality standards, sponsor expectations, and global regulatory guidelines including ICH and applicable SOPs and Work Instructions.
Perform independent validation and peer review of programming deliverables; resolve discrepancies in collaboration with Biostatisticians and cross-functional teams.
Maintain complete, accurate, and audit-ready documentation, including QC records, testing evidence, and programming artifacts.
Manage multiple studies or projects simultaneously, proactively adjusting priorities and timelines to meet business and sponsor needs.
Develop dataset and output specifications of moderate to high complexity, anticipating potential programming risks and ensuring efficient implementation.
Act as Lead Statistical Programmer when assigned, overseeing programming activities, monitoring deliverables, and reviewing key study documents such as SAPs, annotated CRFs, mock shells, and specifications.
Represent statistical programming in sponsor meetings, study kick-offs, and bid defense discussions as required.
Mentor and support junior programmers through training, code review, knowledge sharing, and process guidance.
Contribute to continuous improvement initiatives to enhance programming efficiency, automation, and data visualization capabilities.
Required Qualifications
Education
Advanced degree (Master’s or higher) in Statistics, Computer Science, Data Science, Biostatistics, or a related discipline.
Equivalent education combined with relevant professional experience may be considered.
Experience
Senior Level: Minimum 6–8 years of hands-on statistical programming experience in a clinical research or pharmaceutical environment.
Principal Level: Minimum 9–12 years of advanced statistical programming experience with demonstrated leadership and study-level ownership.
Proven experience delivering clinical trial programming deliverables using R and/or R Shiny; SAS experience strongly preferred.
Demonstrated ability to lead or independently manage complex studies and sponsor-facing deliverables.
Technical Skills
Strong expertise in R programming and R Shiny application development for clinical data analysis and visualization.
Proficiency in SAS; knowledge of Python is an advantage.
In-depth understanding of statistical methods, clinical trial data standards, and analysis workflows.
Experience working in regulated environments with a strong focus on quality, validation, and compliance.
Soft Skills
Excellent analytical, problem-solving, and organizational skills.
Strong written and verbal communication skills in English.
Ability to work independently while collaborating effectively within cross-functional and global teams.
Strong stakeholder management and presentation skills.
Preferred Certifications
SAS Certified Advanced Programmer or equivalent professional certification is preferred but not mandatory.
Why Join Syneos Health
Work on studies supporting 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.
Be part of a diverse, inclusive, and globally connected organization that values innovation and professional growth.
Access continuous learning, career development, and competitive total rewards programs.
Equal Opportunity Statement
Syneos Health is committed to providing equal employment opportunities and complying with all applicable employment laws and regulations. Reasonable accommodations are available for qualified individuals with disabilities.
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