Jobs
>
Redwood City

    Associate Director Biostatistics - Redwood City, United States - Meet

    Meet
    Meet Redwood City, United States

    3 weeks ago

    Default job background
    Description

    Our client is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, our teams around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. We are primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

    Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.

    Summary

    Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems.

    Responsibilities

    • Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.
    • Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.
    • CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.
    • Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities
    • Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

    Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

    Education Qualifications (from an accredited college or university)

    • MS in statistics or biostatistics is required; PhD in statistics or biostatistics is prefered
    • 2 years of Oncology trial support experience required
  • Cargo Therapeutics, Inc.

    Director, Biostatistics

    3 weeks ago

    Cargo Therapeutics, Inc. San Carlos, United States

    The Director, Biostatistics will be responsible for partnering with scientists in Clinical, Safety, Translational Medicine, Regulatory, and Product Development on clinical development projects, development science applications, and/or process/product manufacturing applications, a ...

  • Cargo Therapeutics

    Director, Biostatistics

    3 weeks ago

    Cargo Therapeutics San Carlos, United States

    · The Director, Biostatistics will be responsible for partnering with scientists in Clinical, Safety, Translational Medicine, Regulatory, and Product Development on clinical development projects, development science applications, and/or process/product manufacturing applications ...

  • Arcellx, Inc.

    Associate Director, Biostatistics

    3 weeks ago

    Arcellx, Inc. Redwood City, United States

    Who We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...

  • Meet

    Associate Director Biostatistics

    2 weeks ago

    Meet Redwood City, United States

    Our client is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expe ...

  • ALX Oncology Holdings Inc.

    Director, Biostatistics

    3 weeks ago

    ALX Oncology Holdings Inc. South San Francisco, United States

    ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding dom ...

  • Arcellx, Inc.

    Associate Director, Biostatistics

    2 weeks ago

    Arcellx, Inc. Redwood City, United States

    Who We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...

  • Gilead Sciences

    Associate Director, Biostatistics

    2 weeks ago

    Gilead Sciences San Mateo, United States

    Associate Director - Biostatistician - Virology · United States - California - Foster City · Clinical Development & Clinical Operations · Regular · Job Description · At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such ...

  • Gilead Sciences, Inc.

    Associate Director, Biostatistics

    3 weeks ago

    Gilead Sciences, Inc. Foster City, United States

    For Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...

  • Gilead Sciences, Inc.

    Associate Director, Biostatistics

    3 weeks ago

    Gilead Sciences, Inc. Foster City, United States

    For Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...

  • Ascendis Pharma

    Associate Director, Biostatistics, Oncology

    3 weeks ago

    Ascendis Pharma Palo Alto, United States

    Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, were advancing programs in Endocrinology Rare D ...

  • Gilead Sciences

    Associate Director, Biostatistics

    2 weeks ago

    Gilead Sciences Foster City, United States

    Associate Director - Biostatistician - Virology · United States - California - Foster City · Clinical Development & Clinical Operations · Regular · Job Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases suc ...

  • Gilead Sciences

    Associate Director, Biostatistics

    3 weeks ago

    Gilead Sciences Foster City, United States

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working re ...

  • Vera Therapeutics

    Director, Biostatistics

    3 weeks ago

    Vera Therapeutics Brisbane, United States

    Job Description · Title: Director, Biostatistics · Location: Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that t ...

  • Vera Therapeutics, Inc.

    Director, Biostatistics

    3 weeks ago

    Vera Therapeutics, Inc. Brisbane, United States

    Title: Director, Biostatistics · Location: · Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of ...

  • ALX Oncology Inc.

    Director, Biostatistics

    3 weeks ago

    ALX Oncology Inc. South San Francisco, United States

    ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding dom ...

  • Vera Therapeutics, Inc.

    Director, Biostatistics

    3 weeks ago

    Vera Therapeutics, Inc. Brisbane, United States

    Title: Director, Biostatistics · Location: · Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Veras mission is to advance treatments that target the source o ...

  • Exelixis

    Sr Director, Biostatistics

    3 weeks ago

    Exelixis Alameda, United States

    SUMMARY/JOB PURPOSE: · Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials. Sets direction for ...

  • Cytokinetics

    Associate Director, Biostatistics

    3 weeks ago

    Cytokinetics South San Francisco, United States

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...

  • Cytokinetics, Incorporated

    Associate Director, Biostatistics

    3 weeks ago

    Cytokinetics, Incorporated South San Francisco, United States

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...

  • BeiGene

    Associate Director, Biostatistics

    2 weeks ago

    BeiGene Emeryville, United States

    **General Description:** · Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing and implementing the statistic ...