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    Sr Biostatistician

    Iqvia
    5-7 years
    Not Disclosed
    Bangalore
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: Bachelor’s Degree in Biostatistics or a related field 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 BiostatisticianLocation: Bangalore, India
    Job Type: Full-time
     

    Job Overview

    The Senior Biostatistician will lead complex studies and submissions, overseeing team and site-level operations. This role involves developing protocols, reviewing case report forms (CRFs), and creating analysis plans. The incumbent will communicate with clients regarding study protocols and statistical analysis issues, interpret analyses, and write statistical sections of study reports while ensuring cost control and revenue maximization.

    Essential Functions

    Production of High-Quality Deliverables

    • Complete and review complex tasks with a focus on accuracy, ensuring the same standards are upheld by the team.
    • Prioritize work proactively to enhance efficiency.

    Leadership

    • Act as the lead statistician for complex studies and integrated summaries or eSubmissions.
    • Ensure high-quality deliverables are met on time and within budget while complying with Standard Operating Procedures (SOPs).
    • Manage data quality issues, drive statistical discussions, and provide timely progress updates.
    • Conduct meetings, assess resource needs, and document action items.

    Datasets

    • Write and maintain programming specifications, focusing on efficacy.
    • Oversee dataset derivations and assignments, programming analysis datasets as needed.

    Tables, Listings, and Figures (TLFs)

    • Develop programming specifications for statistical analysis outputs.
    • Check outputs for format and content consistency.

    Timelines

    • Plan, document, and negotiate timelines while forecasting resource needs and identifying out-of-scope work.

    Customer Engagement

    • Serve as the primary point of contact for clients, building and maintaining effective relationships.
    • Provide direction on statistical activities and consult on operational topics.

    Knowledge Sharing

    • Train staff on operational and technical matters.
    • Act as a Subject Matter Expert (SME) to mentor senior staff and contribute to professional development opportunities.

    Risk Management

    • Identify risks to project delivery or quality and implement mitigation strategies.
    • Handle study-level escalations that do not impact client relationships.

    Lock and Unblinding Process

    • Lead the database lock and unblinding process, participating in randomization teams as needed.

    Statistical Expertise

    • Provide expert input into the review of statistical deliverables such as protocols, analysis plans, and reports.
    • Conduct senior biostatistician reviews (SBR) and produce quality control reviews of sample size calculations.

    Financial Management

    • Share accountability for the financial success of assigned studies.
    • Negotiate out-of-scope work and understand contract assumptions.

    Proposals

    • Review proposals at a study level, contributing to requests for proposals (RFPs) and presenting at bid defenses.

    Other Responsibilities

    • Perform additional duties as assigned by senior management.

    Qualifications

    • Education: Bachelor’s Degree in Biostatistics or a related field with 5–7 years of relevant experience required; Master’s Degree preferred.
    • Experience: Typically requires 5–7 years of prior relevant experience or an equivalent combination of education and experience.
    • Knowledge: Advanced knowledge in biostatistics, clinical research regulatory requirements (GCP, ICH), statistical methods applicable to clinical trials, SAS computing package proficiency, and familiarity with other statistical tools like nQuery.
    • Skills: Excellent written and oral communication skills; strong attention to detail; ability to manage multiple projects; team leadership capabilities; problem-solving skills; commitment to quality; ability to establish effective working relationships with colleagues and clients.

    IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We strive to push the boundaries of human science and data science to create a healthier world.

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