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Stat Ii/ Senior/ Principal Stat Programmer (R / R Shiny)

0-2 years
Not Disclosed
10 Oct. 4, 2025
Job Description
Job Type: Full Time Remote 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

🧑‍💻 Position Title:

Stat II / Senior / Principal Statistical Programmer (R / R Shiny)


🌍 Location:

IND-Remote


🆔 Job ID:

25101962


🎯 Job Overview:

Responsible for developing programs and providing statistical programming support for clinical trials. This includes creating datasets, tables, listings, and graphs (TLGs), validating outputs, and ensuring compliance with regulatory standards (CDISC, SDTM, ADaM). Acts as a lead programmer and mentor, supports multiple projects, and contributes to process improvement initiatives.


🌟 Key Responsibilities:

🔹 Programming & Technical Execution

  • Develop custom programming code in SAS (or other software) to generate summary tables, data listings, graphs, and derived datasets per statistical analysis plan and programming specifications.

  • Perform validation programming and resolve discrepancies with statisticians and project team members.

  • Maintain well-organized project documentation, testing, and verification/quality control files ensuring inspection readiness.

  • Develop specifications for datasets and outputs, anticipating programming issues and ensuring accuracy.

  • Contribute to the development of programming tools, macros, and standard operating procedures for efficiency and standardization.

🔹 Project & Team Leadership

  • Lead programming activities and direct work of other programming personnel.

  • Monitor progress on programming deliverables, ensuring on-time delivery and quality.

  • Conduct internal meetings, distribute information, track action items, and ensure team alignment.

  • Participate in sponsor meetings, kickoffs, and bid defenses as statistical programming representative.

  • Mentor junior programmers, provide training, review work, and guide associates on CDISC standards.

🔹 Quality & Compliance

  • Follow SOPs, work instructions, and relevant regulatory guidelines (e.g., ICH).

  • Perform compliance reviews of project deliverables including SDTM and ADaM datasets, DEFINE.XML, and other regulatory-required documents.

  • Serve as a technical SME for CDISC and other regulatory requirements, providing guidance and updates to the biometrics department.


🎓 Qualifications & Requirements:

  • Undergraduate degree in scientific or statistical discipline preferred, or equivalent combination of education and programming experience.

  • Extensive programming experience in SAS or other software, ideally in clinical trials.

  • Experience with CDISC standards for regulatory submissions; regulatory submission experience preferred.

  • Proven ability to lead multiple complex/global projects and mentor others.

  • Excellent written and verbal communication skills in English.

  • Knowledge of clinical drug development and industry standards.

  • Ability to manage multiple priorities and meet deadlines.


Work Environment & Physical Requirements:

  • Remote-based role with minimal travel.

  • Ability to work independently and collaboratively in a dynamic environment.

  • Regular computer use and extended periods of sitting.


🌐 Why Syneos Health:

  • Work with a leading fully integrated biopharmaceutical solutions organization across 110 countries.

  • Career development, training, and mentorship opportunities.

  • Inclusive Total Self culture emphasizing diversity, belonging, and professional growth.

  • Exposure to impactful projects with FDA-approved and EMA-authorized products.


📌 Summary:

Develop and validate statistical programming outputs for clinical trials, lead programming teams, ensure regulatory compliance, mentor staff, and support high-quality deliverables across multiple complex projects.