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    Biostatistician

    Thermo Fisher Scientific
    0-2 years
    Not Disclosed
    Remote
    10 Dec. 11, 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: Lead Statistician
    Location: [Insert Location]
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions:

    • Office-based work

    Job Purpose:

    As a Lead Statistician, you will independently carry out project statistician responsibilities with minimal supervision. Your tasks will include developing analysis databases, conducting statistical analyses, and generating formatted tables and summaries for analysis. You will also provide mentorship to junior team members.

    Key Responsibilities:

    • Ensure compliance with the department's SOPs and follow departmental procedures for statistical analyses and programming work.
    • Lead project teams, conduct team meetings, maintain project timelines, assess and provide resources, and prepare project budgets. Ensure adherence to SOPs and proper project documentation.
    • Interact with sponsors on all aspects of the project.
    • Collaborate with programmers and data management teams to facilitate database maintenance, updates, and documentation. Provide guidance on database structures for analysis.
    • Conduct sample size calculations, review protocols for clinical design completeness, and ensure sound statistical analysis.
    • Develop randomization schemes and ensure appropriate documentation.
    • Create statistical analysis plans, including analysis databases and table/listing specifications. Guide team members in their implementation.
    • Program and validate statistical tables, focusing on efficacy endpoints. Provide accurate documentation and coordinate the work of others assisting with programming and validation.
    • Review reports, documents, and manuscripts, contributing to the statistical methods section and ensuring completeness and consistency.
    • Monitor project budgets in relation to work scope and proactively communicate with management about any potential changes.
    • Support general department activities, such as presentations, teaching, contributing to documents or policies, assisting with newsletters, maintaining libraries, and training new hires.

    Education & Experience:

    • Master's degree or equivalent experience in statistics, biostatistics, mathematics, or a related field.
    • Proven leadership experience: Ability to lead a project team, manage timelines, assess resources, and prepare project budgets.

    Knowledge, Skills & Abilities:

    • Proficient in SAS® programming (BASE, STAT, MACRO, and GRAPH) and understanding of database structures.
    • Ability to provide mentorship and promote teamwork in a multidisciplinary team setting.
    • Strong statistical knowledge and skills.
    • Experience crafting study specifications and reviewing data management documentation.
    • Excellent project management skills, demonstrated through managing multiple projects.
    • Solid written and verbal communication skills, with proficiency in the English language.
    • Strong organizational skills and the ability to adapt to changing priorities.
    • Positive attitude with the ability to work well with others.

    Why Join Us?

    We offer competitive remuneration, professional development opportunities, and a collaborative work environment that values teamwork, innovation, and growth.

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