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Senior Principal Clinical Programmer

0-2 years
Not Disclosed
10 Oct. 4, 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

🧑‍💻 Position Title:

Senior Principal Clinical Programmer


🌍 Location:

IND-Remote


🆔 Job ID:

25101935


🎯 Job Overview:

Serves as a lead Clinical Programmer managing all functional tasks, project deliverables, and large programs of studies. Demonstrates high independence, technical expertise, and leadership in clinical programming and data management. Oversees other lead programmers, ensures regulatory compliance, monitors systems and vendor operations, and provides mentorship.


🌟 Key Responsibilities:

🔹 Leadership & Project Management

  • Lead and coordinate clinical programming activities across single studies or programs of studies.

  • Manage 5–20 concurrent studies depending on scope and resource requirements.

  • Supervise and mentor junior and lead programmers, assign work, review workloads, and conduct performance appraisals.

  • Provide input on study budgets, project-level metrics, and monitor scope versus actual work.

  • Attend client meetings, bid defenses, project reviews, and present updates to senior management.

  • Identify trends across projects and implement strategies to replicate successes or mitigate risks.

🔹 Programming & Technical Expertise

  • Provide technical support and subject matter expertise for clinical programming tools (SAS, Python, Veeva, Spotfire) and data management systems.

  • Understand systems, tools, processes, and data flows, including system/tool migrations (no hands-on required).

  • Monitor applications for workflow alerts, system errors, and performance issues; troubleshoot defects.

  • Perform system integration activities, application updates, and user acceptance testing.

  • Generate and maintain documentation for specifications, coding, validation, edit checks, import/export setups, listings, and custom reports.

🔹 Compliance & Quality Assurance

  • Provide senior review of program-level/multi-study deliverables for accuracy and quality.

  • Attend sponsor audits and assist with in-progress audits.

  • Ensure adherence to SOPs, WIs, regulatory requirements, and internal policies.

  • Lead process improvements, develop programming tools for standardization, efficiency, and emerging customer needs.

🔹 Vendor & Stakeholder Management

  • Manage external application vendors, monitor SLAs, and act as escalation contact.

  • Supervise upgrades and implementation of new vendor modules.

  • Interact with sponsors and internal stakeholders at all levels with senior leadership skills.


🎓 Qualifications & Requirements:

  • Bachelor’s degree required; Master’s preferred, or equivalent experience.

  • Extensive knowledge of clinical programming, data management, and tools (SAS, Python, Veeva, Spotfire).

  • Knowledge of SDTM, data flows, dashboards, and listings; migration experience preferred.

  • Experience mentoring others in clinical trial processes.

  • Excellent communication and interpersonal skills.

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and email/voicemail.

  • Ability to read, write, speak, and understand English.

  • Experience working in a matrix-structured environment preferred.

  • Minimal travel may be required.


🌐 Why Syneos Health:

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

  • Opportunity to work on high-impact projects across global clinical trials.

  • Access to career development, mentorship, and training programs.

  • Involved in projects supporting FDA-approved and EMA-authorized drugs.


📌 Summary:

The Senior Principal Clinical Programmer provides strategic leadership for clinical programming across multiple studies or programs. Ensures high-quality deliverables, oversees other lead programmers, supports data management, monitors applications and vendor activities, and drives process improvements. Acts as a subject matter expert and trusted advisor to internal teams and external stakeholders.