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    Statistical Programmer Ii

    Parexel
    5+ years
    Preferred by Comapny
    India
    16 Nov. 25, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/ B.sc/ IT/ B.tech 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

    Job Description:

    We are seeking an experienced Statistical Programming Coordinator to act as an internal Subject Matter Expertand provide independent support for various programming activities related to the analysis and reporting of clinical study data. This role requires proficiency in SAS programming, excellent communication skills, and a solid understanding of industry technical standards.

    Responsibilities:

    1. Statistical Programming & Coordination:

    • Act as the internal Subject Matter Expert (SME) and support programming activities related to clinical study data analysis and reporting.
    • Perform as the Statistical Programming Coordinator on projects, interacting with Sponsors, Data Operation Leads, and other functions to resolve statistical programming issues.
    • Use efficient programming techniques to produce and QC derived datasets, tables, listings, and figures (TLF).
    • Create and modify standard macros and applications to improve efficiency.
    • Maintain documentation in accordance with WSOPs and guidelines to meet regulatory requirements.

    2. Programming & Development:

    • Develop a wider knowledge of SAS and other relevant programming languages and processes.
    • Work with SQL, PROC reports, SDTM, ADaM (preferred) datasets, and ensure high-quality programming of clinical trial data.
    • Develop and improve programming efficiencies through automation and macros.

    3. Training & Mentorship:

    • Provide relevant training and mentorship to staff and project teams, ensuring they have the required programming skills and knowledge.
    • Act as a leader within the team, guiding less experienced team members and contributing to their professional growth.

    4. Project & People Management:

    • Manage complex projects while maintaining strong leadership and organizational skills.
    • For Associate Manager and Manager roles, people management (LM) experience is required, including managing project teams and ensuring their alignment with project goals.

    5. Communication & Documentation:

    • Ensure clear and effective communication (written and oral) with sponsors and internal stakeholders.
    • Manage all supporting documentation in accordance with SOPs/Guidelines, ensuring regulatory compliance.

    6. Compliance & Regulatory Knowledge:

    • Understand regulatory requirements concerning industry technical standards like WSOPs, ICH-GCP, and System Life Cycle methodologies.
    • Participate in internal/external audits and regulatory inspections as required.

    Requirements:

    • Educational background: Graduate or Master's degree in a relevant field (Life Sciences, Computer Science, Pharmacy, etc.).
    • Experience:
      • Proficiency in SAS with experience in TLF, SAS coding, Macros, SQL, and SDTM/ADaM datasets.
      • Strong experience in programming and reporting processes.
      • Knowledge of WSOPs, ICH-GCP, and System Life Cycle methodologies.
      • Experience in managing complex projects and leading teams (required for Associate Manager/Manager roles).
    • Skills:
      • Excellent communication skills (written and oral).
      • Strong leadership ability with experience in people management (for Manager-level roles).
      • Organizational skills and flexibility to adapt to changes.
      • Ability to work independently and collaborate with cross-functional teams.
      • Competency in written English and effective communication skills.

    Desired Skills:

    • Strong leadership ability to mentor and guide project teams.
    • Ability to manage complex projects, ensure adherence to timelines and budgets, and drive team success.

    This role is ideal for individuals with significant experience in statistical programming who want to lead and mentor teams while ensuring high-quality clinical data analysis and reporting. Proficiency in SAS, SDTM, and ADaM, as well as a solid understanding of regulatory standards, will be key to success in this role.

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