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    Principal Stat Programmer

    Syneos Health
    0-1 years
    Not Disclosed
    Remote - Europe
    10 Nov. 29, 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

    Company: Syneos Health
    Location: Home-based

    About Syneos Health

    Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. They bring unique clinical, medical affairs, and commercial insights to the table to address modern market challenges. With a global presence, Syneos Health places customers and patients at the heart of everything, fostering a culture of innovation and passion.

    Why Syneos Health?

    • Career Growth: Syneos Health is committed to developing its people, offering career development programs, training, recognition, and a total rewards system.
    • Inclusive Environment: The company embraces its Total Self culture, where diversity, backgrounds, and perspectives come together to create a supportive work environment.
    • Global Impact: Syneos Health has played a role in 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the last five years.

    Role Overview

    The Principal Statistical Programmer is a leadership role responsible for managing statistical programming activities for clinical trials. This position requires extensive experience in SAS programming, clinical trials, and CDISC Standards. The programmer will lead complex projects, mentor junior staff, and contribute to the development of programming tools, macros, and industry standards.

    Key Responsibilities

    Programming & Analysis

    • SAS Programming: Develop custom SAS code for summary tables, listings, graphs, and derived datasets as specified in the statistical analysis plan (SAP).
    • Validation & Quality Control: Ensure outputs meet quality standards. Perform validation programming and collaborate with other team members to resolve discrepancies.
    • Dataset & Output Specifications: Develop specifications for datasets and outputs of any complexity, addressing potential programming issues in advance to ensure efficiency.
    • On-time Delivery: Manage programming deliverables across concurrent projects, negotiate timelines, and provide risk mitigation strategies.
    • Documentation: Maintain up-to-date project documentation and quality control records to ensure inspection readiness.

    Leadership & Mentoring

    • Lead Programmer: Oversee and direct the programming activities of other statistical programmers. Monitor progress and ensure deliverables are on schedule.
    • Team Meetings: Conduct internal meetings, track action items, and ensure effective communication within the team.
    • Mentoring: Mentor junior programmers by developing training courses, providing feedback, and guiding new associates.

    Collaboration & Compliance

    • Collaboration: Work with biostatisticians, project managers, and other team members to ensure smooth project execution.
    • CDISC Standards: Serve as a subject matter expert for CDISC and other regulatory standards, providing guidance and training.
    • Compliance Reviews: Perform compliance reviews of deliverables, ensuring they meet regulatory requirements like SDTM and ADaM specifications.

    Technical Expertise

    • Standardization & Tools: Contribute to the development of programming tools and macros to improve standardization and efficiency.
    • Regulatory Submissions: Participate in submissions to regulatory agencies and ensure compliance with CDISC standards.

    Qualifications

    Education & Experience

    • Degree: Undergraduate degree in a scientific or statistical discipline (or equivalent experience).
    • Extensive SAS Experience: Proven experience in SAS programming, preferably within the clinical trial environment, including experience leading multiple complex projects.
    • CDISC Knowledge: Deep understanding of CDISC Standards and regulatory agency requirements. Experience with submissions is preferred.
    • Mentorship: Experience mentoring junior staff and guiding them in clinical trial processes and programming standards.

    Skills

    • Communication: Excellent written and verbal communication skills in English.
    • Leadership: Ability to lead programming teams and manage complex projects with multiple deliverables.
    • Attention to Detail: High standards for accuracy and quality in programming and deliverables.

    Compensation & Benefits

    • Competitive Salary: Compensation is based on experience and qualifications.
    • Benefits: Health benefits, retirement plans, paid time off (PTO), and more.

    How to Apply

    If you are a seasoned statistical programmer with experience in clinical trials and are ready to lead teams, apply today to Syneos Health!

    Note: Syneos Health values diversity and encourages all qualified candidates to apply, even if their qualifications are not a perfect match. They are also open to transferable skills from previous roles.

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