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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


Role Overview

Syneos Health is seeking a Principal Statistical Programmer to lead programming activities for clinical trial data. The role involves developing, validating, and managing deliverables aligned with industry standards like CDISC. This position is pivotal in ensuring high-quality, regulatory-compliant programming outputs while mentoring team members and contributing to process enhancements.


Key Responsibilities

Programming and Data Management

  • Develop custom SAS programs to create summary tables, data listings, graphs, and datasets as per study protocols.

  • Validate programs and resolve discrepancies in collaboration with team members.

  • Prepare datasets and outputs following CDISC Standards (SDTM, ADaM) and regulatory requirements.

Project and Team Leadership

  • Serve as the lead statistical programmer, overseeing multiple complex or global projects.

  • Coordinate with biostatisticians and project team members to ensure timely delivery of quality outputs.

  • Mentor programming personnel, offering training and guidance on best practices and industry standards.

Process Optimization and Compliance

  • Maintain comprehensive project documentation for inspection readiness.

  • Establish and contribute to SOPs and internal guidelines to standardize operations.

  • Actively participate in industry standards organizations, keeping the team informed on updates to CDISC or regulatory requirements.

Communication and Collaboration

  • Participate in sponsor meetings, including bid defense and project kickoff sessions.

  • Effectively manage time across projects, adapt to shifting priorities, and proactively communicate progress to stakeholders.


Qualifications

Education and Experience

  • Bachelor’s degree in Scientific or Statistical disciplines or equivalent experience.

  • Extensive programming experience in SAS or similar software, ideally within a clinical trial environment.

  • Proven expertise in CDISC Standards and regulatory submissions.

Skills and Competencies

  • Advanced programming and data analysis skills.

  • Excellent verbal and written communication.

  • Experience in leading and mentoring statistical programming teams.

  • Strong organizational skills and ability to multitask in dynamic environments.

Language

  • Fluency in English (spoken and written).


Why Syneos Health?

Workplace and Culture

  • A global leader in biopharmaceutical solutions with a focus on patient-centered innovations.

  • Collaborative culture encouraging diversity of thought and authenticity.

Professional Growth

  • Robust training programs, career development opportunities, and recognition initiatives.

  • Exposure to industry-leading projects, working with cutting-edge clinical trial processes.


Application Details

Take the lead in transforming clinical trial programming by joining Syneos Health. Apply now or join our Talent Network to explore future opportunities.