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    Associate Director, Statistical Programming

    Novartis
    3-10 years
    Not Disclosed
    London
    10 Jan. 31, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Associate Director, Statistical Programming

    Location: London (The Westworks)

    Job Type: Full-time

    Application Deadline: March 28, 2025

    Job Summary:

    Novartis is seeking an Associate Director, Statistical Programming to lead statistical programming activities for early drug development programs within Immunology, Cardiovascular & Metabolic Diseases, or Neuroscience. This role involves strategic decision-making, cross-functional collaboration, and regulatory compliance to ensure high-quality and timely data delivery.

    The ideal candidate will have strong leadership experience, expertise in SAS/R programming, a solid understanding of clinical trials methodology, and a background in early development, preferably in oncology.

    Key Responsibilities:

    Strategic & Operational Leadership:

    • Lead statistical programming (SP) activities for multiple clinical trials within a program or indication/disease area.
    • Make strategic statistical programming decisions at the program or indication level.
    • Develop scientific documentation in collaboration with Biostatisticians.
    • Represent Statistical Programming (Early Development) in audits, inspections, Health Authority (HA) meetings, and industry conferences (e.g., CDISC).

    Resource & Team Management:

    • Allocate and manage resources within and across programs.
    • Supervise, mentor, and develop internal and external statistical programmers (managing teams of 6-15 programmers).
    • Conduct performance appraisals and provide career development support.

    Cross-functional Collaboration & Communication:

    • Build and maintain effective relationships with clinical trial and program team members.
    • Summarize and communicate programming deliverables, timelines, and resource plans across functions.
    • Ensure regulatory compliance and readiness for Health Authority inspections.

    Technical Expertise & Compliance:

    • Maintain advanced knowledge of SAS/R programming and statistical reporting techniques.
    • Ensure adherence to CDISC, eCTD, Define.xml, and regulatory standards.
    • Drive innovation and efficiency in statistical programming practices.

    Qualifications & Experience:

    Education & Industry Experience:

    • BS/MS degree in Life Sciences, Computer Science, Statistics, Mathematics, or a related field.
    • 10+ years of industry experience, with 6+ years in statistical programming.
    • 2+ years as a Lead/Program/Project Programmer for one or more programs/indications.
    • 3+ years of line or matrix management experience (for people managers).

    Technical & Business Skills:

    • Expertise in SAS or R programming (including development and validation of deliverables).
    • Experience in developing advanced MACROs and statistical programming functions.
    • Strong knowledge of CDISC standards, regulatory submissions, and industry best practices.
    • Deep understanding of clinical trial methodology, regulatory requirements, and GCP.
    • Ability to manage multiple trials simultaneously while meeting tight deadlines.

    Preferred Experience:

    • Prior early development experience, ideally in Oncology.
    • Strong interpersonal and leadership skills to operate in a global environment.

    Skills & Competencies:

    • Statistical Analysis & Data Structures
    • Clinical Trial Data Programming
    • Cross-functional Team Collaboration
    • People Management & Leadership
    • Regulatory Compliance (CDISC, GCP, eCTD, Define.xml)
    • Project & Risk Management
    • Programming Languages (SAS/R)
    • Data Analysis & Reporting

    Languages Required:

    • English (Fluent)

    Why Join Novartis?

    • Innovative Science: Work at the forefront of drug development and statistical programming.
    • Career Growth & Development: Opportunities to lead, mentor, and shape statistical programming strategies.
    • Global Impact: Contribute to life-changing treatments in Immunology, Cardiovascular & Metabolic Diseases, and Neuroscience.
    • Collaborative & Inclusive Culture: Work in a diverse, global team that supports and inspires innovation.

    🚀 Join Novartis and be a part of groundbreaking medical advancements!

    Commitment to Diversity & Inclusion:

    Novartis is committed to fostering an inclusive and diverse workplace that reflects the communities we serve. We encourage applications from all backgrounds.

    Join Our Talent Network:

    If this role isn't the right fit, stay informed about future career opportunities by signing up for our Novartis Talent Network here: Novartis Careers

    📢 Please note that visa sponsorship is currently unavailable for this position.

    #Novartis #StatisticalProgramming #ClinicalTrials #SAS #RProgramming #CDISC #Biostatistics #PharmaceuticalCareers

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