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Sr Principal Stat Programmer

2+ years
Not Disclosed
10 Dec. 1, 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

The job description for the Senior Principal Statistical Programmer at Syneos Health emphasizes leadership, technical expertise, and compliance in statistical programming within clinical research. Below is an overview:


Position Overview

Location: Home-Based, India-Asia Pacific
Updated: November 25, 2024
Job ID: 24006304

The Senior Principal Statistical Programmer provides strategic, technical, and leadership expertise in statistical programming. This role supports clinical development activities and compliance with regulatory requirements, industry standards, and company protocols.


Key Responsibilities

  1. Programming Expertise:

    • Develop custom programming code using SAS or other software for generating datasets, summary tables, and graphics.
    • Act as a subject matter expert in CDISC standards, including SDTM and ADaM datasets.
  2. Innovation & Process Improvement:

    • Lead process improvements and develop programming tools/macros to enhance standardization and efficiency.
    • Analyze challenges and implement innovative solutions for data analysis and programming.
  3. Leadership & Mentorship:

    • Mentor Biometrics team members in advanced approaches and technologies.
    • Provide oversight to Lead Statistical Programmers on multiple projects.
  4. Regulatory Compliance & Standards:

    • Ensure compliance with ICH guidelines, regulatory standards, and company SOPs.
    • Support and perform compliance reviews for CDISC deliverables and other regulatory documents.
  5. Cross-Functional Collaboration:

    • Provide input on CRFs, Statistical Analysis Plans, and mock shells.
    • Serve as the primary contact for clients and represent the department at meetings.
  6. Documentation & Quality Assurance:

    • Maintain project documentation to ensure inspection readiness.
    • Establish and meet project timelines, providing regular updates on progress.
  7. Business Development:

    • Contribute to proposals, budgets, and bid defense meetings for new business opportunities.

Qualifications

  • Education:

    • Undergraduate degree in scientific or statistical disciplines, or equivalent experience.
  • Experience:

    • Extensive experience in statistical programming in clinical trials, preferably with global or complex projects.
    • Proficiency in CDISC Standards and SAS programming.
    • Experience in regulatory submissions and mentorship.
  • Skills:

    • Strong communication and presentation abilities.
    • Excellent problem-solving, project management, and organizational skills.
    • Knowledge of clinical drug development and industry standards.
  • Preferred:

    • Participation in publications or presentations.

Why Syneos Health?

  • Collaborate on groundbreaking clinical trials, contributing to 94% of FDA-approved drugs in the last five years.
  • Benefit from career development programs, training, and recognition.
  • Thrive in an inclusive culture that values diversity, innovation, and authenticity.

Application Information

Candidates are encouraged to apply directly or join the Talent Network to stay updated on career opportunities. Syneos Health values transferable skills and a diverse workforce.

For more information or to apply, click here.