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    Sr Statistical Programmer (Adam / Tfl's+ Sdtm)

    Syneos Health
    2+ years
    Not Disclosed
    India
    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 Senior Statistical Programmer position at Syneos Health is a leadership role in the clinical development team, focusing on the programming and analysis of clinical trial data. The role involves working with SAS or other software to generate summary tables, data listings, graphs, and derived datasets, as well as ensuring that all outputs meet the highest standards of quality.

    Position Overview

    Location: Home-Based, India-Asia Pacific
    Updated: November 18, 2024
    Job ID: 24006021

    As a Senior Statistical Programmer, you will lead programming activities, ensure accurate and timely data analysis, and guide junior programmers. You will work closely with biostatisticians, project teams, and sponsors to ensure programming specifications are met.

    Key Responsibilities

    1. Programming and Data Analysis:

      • Develop SAS or other software code to create statistical outputs such as tables, listings, graphs, and derived datasets.
      • Ensure that all outputs meet quality standards and are aligned with statistical analysis plans.
      • Perform validation programming and collaborate with other team members to resolve discrepancies.

    2. Documentation and Project Management:

      • Maintain organized, complete, and up-to-date project documentation.
      • Follow SOPs and regulatory guidelines (e.g., ICH).
      • Effectively manage multiple projects, meet deadlines, and adapt to timeline changes.

    3. Leadership and Mentorship:

      • Lead the programming activities of other programmers and ensure programming deliverables are met on time.
      • Provide mentorship and guidance to junior programming personnel, including developing training courses and materials.

    4. Collaboration and Communication:

      • Participate in sponsor meetings and act as the statistical programming representative.
      • Contribute to project documentation such as the Statistical Analysis Plan and programming specifications, and provide feedback to improve efficiency.

    5. Stakeholder Engagement:

      • Engage with project teams, sponsors, and other stakeholders to ensure effective communication and understanding of project requirements.
      • Represent statistical programming in meetings such as bid defenses and study kickoff sessions.

    6. Quality and Compliance:

      • Perform quality control and testing on programming outputs to ensure accuracy and completeness.
      • Maintain inspection readiness for all project documentation.

    Qualifications

    • Education:

      • Undergraduate degree in a scientific or statistical discipline (or equivalent experience in clinical trial programming).

    • Experience:

      • Extensive programming experience with SAS or other required software, preferably in a clinical trial environment.
      • Strong understanding of statistical programming concepts, clinical trial data structures, and regulatory guidelines.

    • Skills:

      • Excellent written and verbal communication skills.
      • Ability to read, write, speak, and understand English fluently.
      • Strong time management and organizational skills to handle multiple projects and deadlines.

    Why Syneos Health?

    • Culture:
      Syneos Health emphasizes a diverse, inclusive work environment and fosters career development through training, mentorship, and recognition.

    • Impact:
      The company has supported over 94% of all Novel FDA Approved Drugs, making a substantial impact in clinical trials globally.

    Application Information

    This is an exciting opportunity to take a leadership role in statistical programming within the biopharmaceutical industry. If you meet the qualifications and are eager to contribute to innovative clinical trials, Syneos Health invites you to apply.

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