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Senior/ Principal Statistical Programmer (R/Rshiny)

10+ years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior / Principal Statistical Programmer (R / RShiny)

Updated: December 4, 2025
Location: India – Remote
Job ID: 25103962
Category: Statistical Programming | Clinical Development | Biostatistics

Syneos Health is a global, fully integrated biopharmaceutical solutions provider committed to accelerating clinical development and delivering data-driven outcomes. With more than 29,000 professionals across 110 countries, the organization partners with leading pharmaceutical, biotechnology, and life science companies to advance innovative therapies.

The Senior / Principal Statistical Programmer (R/RShiny) plays a strategic role in programming, analytics, data visualization, and advanced statistical output generation for clinical trials. This is a remote position supporting global studies and cross-functional teams.


Position Overview

The role involves end-to-end programming responsibilities using R, RShiny, SAS, and related analytics tools. You will support complex clinical studies, lead programming activities, validate outputs, ensure regulatory compliance, and provide technical oversight to junior programmers. This role is suitable for highly analytical professionals with strong hands-on coding experience in clinical data environments.


Key Responsibilities

Statistical Programming & Analysis

  • Develop custom programming code using R, RShiny, SAS, or other analytics software to generate tables, listings, figures, and derived datasets based on Statistical Analysis Plans (SAPs) and programming specifications.

  • Validate statistical outputs, identify issues, and collaborate with Biostatisticians and cross-functional team members to resolve discrepancies.

  • Ensure all outputs meet internal quality standards, regulatory expectations (ICH), and project timelines.

Documentation & Compliance

  • Maintain complete, well-organized, and inspection-ready documentation, including test scripts, quality control outputs, and validation records.

  • Follow all applicable SOPs, work instructions, and regulatory guidelines.

Project Leadership & Coordination

  • Lead programming activities across multiple studies, managing timelines, deliverables, and workload.

  • Review project documentation such as SAPs, mock shells, CRFs, and programming specifications.

  • Guide team members and coordinate programming workflows to meet sponsor requirements with minimal rework.

Team Collaboration & Communication

  • Prepare for internal and sponsor meetings, contribute insights, and support problem-solving discussions.

  • Conduct or lead meetings when required, ensuring documentation, follow-ups, and timely completion of action items.

  • Mentor junior programmers, develop training material, review code, and support onboarding of new associates.

Sponsor & Cross-Functional Interaction

  • Participate in sponsor discussions, kick-off meetings, and bid defense meetings as the statistical programming representative.

  • Support study teams and demonstrate adaptability in fast-paced, evolving project environments.

Additional Responsibilities

  • Assist in the transition of deliverables.

  • Perform other statistical programming or project-related duties as assigned.

  • Minimal travel may be required.


Required Qualifications & Experience

  • Master’s or advanced degree in Statistics, Computer Science, Mathematics, Data Science, or a related field.

  • Minimum 5–10 years of statistical programming experience in clinical trials, CROs, or pharmaceutical environments (for Senior).

  • 10+ years of progressive experience with leadership responsibilities (for Principal level).

  • Strong programming proficiency in R, RShiny, SAS, or Python, with proven experience in clinical trial data.

  • Advanced understanding of statistical methodologies, CDISC standards, and regulatory submission expectations.

  • Excellent analytical and problem-solving abilities.

  • Ability to manage multiple projects, work independently, and collaborate effectively with global teams.

  • Strong written and verbal communication skills.


Preferred Certifications

  • SAS Certified Advanced Programmer for SAS 9 or equivalent recognized certification.

  • Additional programming or data science certifications are an advantage.


Core Skills & Competencies

  • Expertise in clinical statistical programming and data analysis.

  • Excellent understanding of biostatistics and clinical data structures.

  • Strong technical documentation skills and attention to detail.

  • Experience leading programming teams and mentoring junior staff.

  • Ability to deliver high-quality outputs under strict timelines.


Why Syneos Health

  • Contributed to 94 percent of all Novel FDA Approved Drugs and 95 percent of EMA Authorized Products in the past five years.

  • Supported over 200 clinical studies across 73,000 sites and 675,000 trial participants.

  • Offers continuous professional development, technical training, leadership support, and a global culture of inclusion.

  • A workplace built on the Total Self culture, encouraging authenticity, collaboration, and growth.

Learn more at syneoshealth.com.


Additional Information

This job description is not exhaustive. Syneos Health may assign additional responsibilities based on operational requirements. Equivalent education or experience may be considered. The company complies with international regulatory requirements, equal opportunity laws, and the Americans with Disabilities Act, providing reasonable accommodations where appropriate.


How to Apply

Submit your application through the Syneos Health Careers Portal or join the Talent Network to receive updates on new opportunities.