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    Biostatistician Ii

    Parexel
    2-5 years years
    2-4 LPA
    Remote
    15 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, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Vacancy: Biostatistician II

    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 will contribute to research design and analytical strategies, provide input into protocols, and develop and review statistical analysis plans, all while working with 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 II is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. They develop collaborative relationships and work effectively with the GBDS (Global Biometric & Data Sciences) Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians II are individual contributors and report to a GBDS Lead.

     

    Key Responsibilities:

    • Independently lead the development and execution of statistical aspects for studies of low to moderate complexity.
    • Participate in PRC reviews of study protocols and SAPs.
    • Provide data interpretation for study documents, e.g., CSR.
    • Contribute to the preparation of the development strategy for effective and safe product utilization.
    • Develop trial designs that address study objectives to support regulatory approval and market access.
    • Translate scientific questions into statistical terms and statistical concepts into layman's terms.
    • Challenge collaborator assumptions and provide insights based on available information.
    • Ensure all analyses have clearly articulated hypotheses and that trial design and data collected support the analysis.
    • Communicate effectively with clinical and regulatory partners and external opinion leaders.
    • Author and/or review protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications, and other study level specification documents.
    • Exercise cost-disciplined science in trial sizing and analysis planning.
    • Comply with BMS processes and SOPs, global and project standards, and ensure quality of deliverables.
    • Ensure programming team or vendor partner understands the nature of the clinical data and summarizing approaches.
    • Collaborate with clinicians and medical writers to prepare summaries of results for regulatory documents and scientific articles.
    • Drive interpretation of results, key message development, and communication to the development team.
    • Align study team and escalate issues to the GBDS Lead for resolution.
    • Provide statistical consultation for ad hoc analysis requests.
    • Ensure quality in all planning, design, and execution of assignments.
    • Stay updated with state-of-the-art applied statistical methodology.
    • Understand CDISC standards and implementation guides.

     

    Skills, Knowledge, and Experience:

    Minimum Requirements:

    • Master's degree in Statistics or equivalent & ≥ 3 years of industry-related experience. -OR-
    • Ph.D. 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.
    • Excellent verbal and written communication skills.
    • Flexibility and adaptability to changing organizational needs.
    • Ability to organize multiple work assignments and establish priorities.
    • Strong interpersonal skills and ability to develop relationships within the organization.

     

    Project Statistician Specifics:

    • Demonstrated knowledge of statistical/clinical trials methodology related to clinical development.
    • Relevant prior data analysis planning, execution, and delivery experience.

     

    Why Biostatisticians Work at Parexel

    Learn about our culture and explore why Biostatisticians choose to work at Parexel.

     

    Employee Insights

    Gain insights from our employees about their experiences and career paths at Parexel.

     

    Potential Career Path

    Discover the potential career paths and growth opportunities available for Biostatisticians at Parexel.

     

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