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    Statistical Programming Lead

    Johnson & Johnson
    6-8 years
    Not Disclosed
    Mumbai
    10 Sept. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Title: Statistical Programming Lead

    Function: Data Analytics & Computational Sciences
    Sub Function: Business Intelligence
    Category: Senior Analyst, Business Intelligence (P6)
    Location: Mumbai, Maharashtra, India
    Date Posted: September 12, 2024
    Requisition Number: 2406184377W

    Position Summary:

    The Statistical Programming Lead is a seasoned Statistical Programmer with deep expertise in statistical programming methods, languages, and data structures. This role involves leading analysis and reporting activities and managing programming teams according to departmental standards. You will oversee and guide programming activities for clinical projects, ensuring the efficient, timely, and high-quality delivery of programming outputs.

    As a leader in statistical programming, you will make critical decisions that impact project efficiency and quality. Your role includes providing technical and project-specific guidance, developing programming strategies, and contributing to process improvements and innovation within the Therapeutic Area or department.

    Principal Responsibilities:

    • Team Leadership:

      • Manage and direct a Statistical Programming team, ensuring timely and high-quality deliverables for clinical projects of varying complexity.
      • Oversee team activities, provide technical guidance, and ensure adherence to departmental processes and standards.

    • Programming Oversight:

      • Develop and implement detailed programming strategies, specifications, and plans for clinical projects.
      • Perform comprehensive reviews of project requirements and documentation.
      • Collaborate with statistical programming and cross-functional team members to achieve project goals.
      • Oversee outsourced programming activities to ensure external vendors meet quality and timeline expectations.

    • Advanced Programming:

      • Design and develop programs for complex clinical data analysis and reporting.
      • Utilize technical and analytical expertise to enhance efficiency and quality in clinical project programming.
      • Lead or contribute to expertise areas that improve deliverable quality across multiple projects.

    • Process Improvement:

      • Participate in or lead departmental innovation and process improvement initiatives.
      • Ensure compliance with company training, time reporting, and operational processes.

    • Key Relationships:

      • Report to a people manager within the functional area and be accountable to the Statistical Programming Portfolio Lead.
      • Interface with various functional contacts within IDAR, including Statistical Programming Portfolio Lead, Statistical Programmers, Data Management, and Regulatory Medical Writing.
      • Collaborate with Janssen's Clinical Trial Leads, Quantitative Sciences, Biostatisticians, and other regulatory and clinical teams.
      • Engage with external partners and CROs as necessary.

    Qualifications:

    • Education:

      • Bachelor's degree or higher in computer science, mathematics, data science/analytics, public health, or a related scientific field.

    • Experience:

      • Approximately 6-8 years of programming experience with increasing responsibility, ideally within a pharmaceutical or clinical trial setting.
      • Advanced proficiency in statistical programming languages, including SAS (required), and knowledge of other languages such as R or Python (preferred).
      • Proven experience in planning and coordinating programming activities and leading teams.
      • Experience working with cross-functional teams and stakeholders.
      • Working knowledge of regulatory guidelines (e.g., ICH-GCP) and clinical R&D concepts.

    • Skills:

      • Basic project management skills.
      • Strong written and verbal communication abilities.

    If you are a highly skilled Statistical Programmer with leadership experience and a passion for enhancing clinical programming processes, we encourage you to apply. For more details about the role and our organization, please visit our career page.

    Janssen Pharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

    #LI-JJ1

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