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    Biostatistician I

    Parexel
    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    2-4 LPA
    Remote
    10 July 11, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D, Nursing 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 Vacancy: Biostatistician I

    Location: India, Remote
    Additional Locations: Bengaluru, Karnataka; Chandigarh, Punjab; Hyderabad, Telangana; Mumbai, Maharashtra; SAS Nagar (Mohali), Punjab

     

    Overview

    As a member of Parexel’s Biostatistics group, your expertise in statistical methodology and data analysis plays a crucial role in providing evidence to support the safety and efficacy of new health treatments. You contribute to research design and analytical strategies, provide input into protocols, and develop and review statistical analysis plans, all while keeping the patient in mind.

    Parexel's Biostatisticians work in global cross-functional teams where idea-sharing is encouraged, and continuous learning is a part of the culture. Our flexible, supportive, and inclusive working environment allows you to work at your best, voice your opinions, and contribute to the success of the team.

     

    Success Profile

    To succeed at Parexel, you should possess the following soft skills and interpersonal traits:

    • Analytical
    • Collaborative
    • Detail-oriented
    • Efficient
    • Problem-solver
    • Quality-focused

     

    About This Role

    Position Summary: The Biostatistician I is a member of cross-functional development teams and contributes (with supervision) to activities that may include developing the statistical methods section of clinical protocols, developing Statistical Analysis and/or Data Presentation Plans, statistical data review, statistical analysis, and interpretation. They also contribute to the development of clinical study/integrated reports, regulatory responses, and scientific publications (including abstracts and congresses).

    Biostatisticians I are individual contributors and report to a Global Biometrics & Data Sciences (GBDS) Functional Lead. They must be able to work in an environment with supervisory oversight and show a willingness to learn and adapt to changing study needs in support of broader team deliveries.

     

    Key Responsibilities:

    • Perform preplanned statistical analyses, e.g., from the SAP or DPP, with supervision.
    • Present analysis results and interpretations to the GBDS team.
    • Provide internal GBDS review of other SAPs, results, and CSRs.
    • Have knowledge of results outside traditional statistical expertise in clinical, regulatory, and commercial environments and their impact on the development team.
    • Engage as a GBDS team member to learn the drug development process.
    • Assist in developing presentations of analyses to key stakeholders.
    • Be knowledgeable of statistical methodology and its appropriate application in trial design and data analysis for clear, concise, high-quality results.
    • Have an understanding of statistical/clinical trials methodology as it relates to clinical development.
    • Understand data analysis planning, execution, and delivery.
    • Understand CDISC standards and implementation guides.

     

    Skills, Knowledge, and Experience:

    Minimum Requirements:

    • BS degree in Statistics or equivalent & ≥ 3 years of industry-related experience. -OR-
    • Master's degree in Statistics or equivalent & ≥ 1 year of industry-related experience.

    Preferred Requirements:

    • Ability to work successfully within global cross-functional teams leading to successful regulatory filings and approvals.
    • Strong verbal and written communication skills.
    • Flexibility and adaptability to changing organizational needs.
    • Ability to organize multiple work assignments and establish priorities.
    • Good interpersonal skills with peers and adjacent functions (e.g., statistical programming).

    Biostat Specifics (Preferred):

    • Working knowledge of statistical/clinical trials methodology as it relates to clinical development.
    • Relevant prior data analysis planning, execution, and delivery experience.

     

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