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    Principal Stat Programmer (Adam, Tlf's , Sdtm)

    Syneos Health
    2+ years
    Not Disclosed
    Gurugram
    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 18, 2024
    Location: India-Asia Pacific - Gurugram, DLF Downtown
    Job ID: 24006019

    Job Description

    Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success. We bring clinical, medical affairs, and commercial insights together to address modern market challenges. Our mission is to simplify and streamline our work to make us easier to work with—and easier to work for. We are driven to innovate and change lives through collaboration.

    Job Responsibilities

    • Programming & Data Generation:

      • Develop custom SAS programming code to generate summary tables, data listings, graphs, and derived datasets based on the statistical analysis plan and programming specifications.
      • Ensure that all outputs meet quality standards and project requirements.
      • Perform validation programming, working with other team members to resolve discrepancies.

    • Project Management & Documentation:

      • Keep project team members informed of progress and issues that require attention.
      • Follow relevant SOPs, WIs, and regulatory guidelines (e.g., ICH).
      • Maintain organized, complete, and up-to-date project documentation, testing, verification, and quality control documents to ensure inspection readiness.
      • Manage multiple projects, adapt to timeline changes, and reorganize daily workloads as necessary.
      • Develop specifications for datasets and outputs based on statistical or sponsor requirements.
      • Conduct internal meetings to ensure effective communication and resolution of issues.

    • Leadership & Mentorship:

      • Lead programming activities, directing and monitoring the progress of other programming personnel.
      • Review project documentation, provide feedback to the team, and contribute to the creation of specifications and standards.
      • Mentor programming personnel by developing training materials and providing feedback.
      • Act as a technical expert on CDISC Standards and regulatory requirements (e.g., SDTM, ADaM), offering guidance and training to others.
      • Contribute to the development of programming tools and macros for efficiency.

    • Compliance & Regulatory:

      • Serve as a subject matter expert for CDISC Standards, ensuring compliance in project deliverables and regulatory submissions.
      • Review and provide feedback on project deliverables such as SDTM and ADaM datasets and regulatory-required documents.
      • Actively participate in industry standards organizations and provide updates to the department on changes in standards.

    • Collaboration:

      • Participate in sponsor meetings and bid defense meetings as the statistical programming representative.
      • Work collaboratively with biostatistics and statistical programming personnel to establish SOPs and policies.

    Qualifications

    • Education: Undergraduate degree, preferably in a scientific or statistical discipline. Equivalent experience may be considered.
    • Experience:
      • Extensive programming experience in SAS or other required software, ideally in a clinical trial environment.
      • Proven ability to lead multiple complex or global projects.
      • Knowledge and experience with CDISC Standards, regulatory submissions, and clinical trial processes.
      • Experience mentoring others in clinical trial processes and CDISC Standards.
    • Skills:
      • Excellent written and verbal communication skills.
      • Ability to read, write, speak, and understand English proficiently.

    Additional Information

    • Travel: Minimal travel may be required.
    • Impact: Syneos Health has contributed to 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years, with involvement in over 200 studies globally.

    Apply for this Job

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    Syneos Health is committed to building a diverse and inclusive workplace. We encourage applicants to apply even if their qualifications don't align perfectly with the role, as transferable skills will be considered.

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