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Principal Stat Programmer

2+ years
Not Disclosed
10 Dec. 2, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Principal Statistical Programmer

Updated: November 26, 2024
Location: United Kingdom (Home-Based)
Job ID: 24006450


About Syneos Health

Syneos Health® is a global biopharmaceutical solutions organization dedicated to advancing therapies through innovation. We operate at the intersection of clinical development, medical affairs, and commercialization, striving to deliver better outcomes for customers and patients.


Why Join Us?

  • Professional Growth: Access to comprehensive training, career advancement opportunities, and mentorship programs.

  • Inclusive Culture: A commitment to diversity, inclusion, and fostering a workplace where all employees feel they belong.

  • Meaningful Work: Collaborate with a global team of 29,000 professionals impacting healthcare in over 110 countries.


Key Responsibilities

Programming Leadership

  • Develop and validate SAS programming for clinical trial data analysis, including summary tables, listings, graphs, and datasets.

  • Lead programming activities for global, complex projects, ensuring compliance with CDISC Standards (SDTM, ADaM).

  • Provide technical guidance and mentor team members, contributing to their professional development.

Regulatory and Quality Standards

  • Ensure all outputs meet regulatory guidelines (e.g., ICH) and sponsor specifications.

  • Serve as a subject matter expert in CDISC standards, advising teams and conducting compliance reviews.

  • Maintain up-to-date documentation and inspection-ready deliverables.

Collaboration and Communication

  • Coordinate with biostatisticians, project managers, and sponsor representatives to address programming needs.

  • Participate in meetings, including sponsor kickoff and bid defense sessions, as the programming lead.

  • Communicate project status, timelines, and risks to stakeholders proactively.

Innovation and Efficiency

  • Develop and implement programming tools and macros to enhance efficiency and standardization.

  • Contribute to SOPs and internal policies, ensuring streamlined operations.

  • Stay updated on industry trends and participate in standards organizations to align with evolving regulatory requirements.


What We’re Looking For

Education and Experience

  • Degree: Bachelor's in a scientific or statistical field preferred; equivalent experience considered.

  • Programming Expertise: Extensive SAS programming experience, particularly in a clinical trial environment.

  • CDISC Knowledge: Proficient in regulatory-compliant standards (SDTM, ADaM); prior submission experience is a plus.

Skills

  • Proven ability to manage multiple complex projects and deliverables.

  • Strong leadership and mentoring capabilities.

  • Excellent communication skills, both written and verbal.

  • Fluency in English is required.


Additional Information

  • Minimal travel may be required.

  • Syneos Health is an equal-opportunity employer, fostering a culture of inclusion and authenticity.

  • We welcome candidates with diverse experiences, encouraging applications even if all qualifications are not met.


Join Us Today!
Be part of a team that’s transforming healthcare through innovation and collaboration. Apply now or join our Talent Network to explore future opportunities.


For more details about Syneos Health and our career opportunities, visit our website.