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    Senior Clinical Project Statistician

    Eli Lily
    1-3 years
    Not Disclosed
    Cork
    10 Jan. 31, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, 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: Senior Clinical Project Statistician
    Location: Cork, Cork, Ireland
    Category: Research & Development
    Job Type: Full Time, Regular
    Job Id: R-75223

    Company Overview:

    At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, Eli Lilly operates with a global workforce that strives to discover and bring life-changing medicines to those who need them. We are committed to advancing the understanding and management of diseases and giving back to our communities through philanthropy and volunteerism.

    Lilly Cork Overview:

    Eli Lilly Cork is home to over 2,000 employees from 60 nationalities, providing innovative solutions across various business functions, including Finance, Information Technology, Medical, and Clinical Trials. Our Cork campus offers a premium workspace with flexible hybrid working options, competitive benefits including healthcare, pension, life assurance, subsidized canteen, on-site gym, travel subsidies, and parking. We also focus on employee wellbeing, development, and diversity.

    Job Purpose:

    The Senior Clinical Project Statistician is responsible for developing and supporting clinical trial protocols, statistical analysis plans, and data analyses in collaboration with physicians, clinical research scientists, and other research colleagues. This role also involves working with research associates and scientists to establish reporting databases and analyzing clinical study data.

    Primary Responsibilities:

    Statistical Trial Design and Analysis:

    • Contribute to study protocol design and authorship.
    • Select appropriate statistical methods for data analysis and write the statistical analysis plan.
    • Analyze data after the creation of the reporting database.
    • Collaborate with data sciences in the development and execution of data quality assurance plans.
    • Stay current with statistical methodologies and ensure proficiency in applying and justifying statistical methods.

    Communication of Results and Inferences:

    • Collaborate with team members to write reports and communicate results.
    • Present study results through regulatory submissions, manuscripts, oral presentations, and scientific meetings.
    • Respond to regulatory queries and engage with regulators.

    Therapeutic Area Knowledge:

    • Understand disease states, competitive landscapes, and the regulatory environment to enhance collaboration and scientific contributions.

    Regulatory Compliance:

    • Perform work in full compliance with applicable Corporate, Medical, local, and departmental policies and procedures.

    Statistical Leadership and Teamwork:

    • Introduce and apply innovative methodologies and tools to solve complex problems.
    • Lead projects independently and collaborate effectively across functions.
    • Apply technical expertise to influence business decisions.

    Minimum Qualification Requirements:

    • Education: M.S. or Ph.D. in Statistics, Biostatistics, or a related field (e.g., Mathematics, Epidemiology).
    • Experience: Relevant experience in clinical trials and statistical analysis, including designing and conducting trials, statistical analysis, and authoring related protocols.

    Additional Preferences:

    • Proficiency in statistical programming languages/software (SAS, R, Spotfire, WinBUGs, etc.).
    • Strong interpersonal communication skills for effective customer consultation.
    • Leadership and teamwork abilities, with demonstrated problem-solving and critical thinking skills.
    • Ability to manage competing deliverables and timelines.
    • Resource management skills and creativity in applying statistical analysis methods.
    • Familiarity with regulatory submissions and associated business processes.

    Other Information:

    • Work shift: Full-time, standard work shift.
    • Travel required: 5-10% of the time.

    Equal Opportunity Employment:

    Lilly is committed to creating an inclusive environment where all employees are empowered to contribute their best. We are an Equal Opportunity Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

    Join Our Team:

    We are looking for dynamic, creative individuals who are committed to improving patient outcomes through innovative statistical methods and research. If you want to make a meaningful impact, apply today and be part of a global leader in healthcare.

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