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Arcellx
Redwood City, CA, 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 mission is to destroy cancer and advance humanity by developing cell therapie
Job Source: ArcellxArcellx, Inc.
Redwood City, CA, United States
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Job Source: Arcellx, Inc.Cytokinetics
South San Francisco, CA, United States
Responsibilities Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams Oversee all the studies for one compound to ensure the consistency of statistical work standards as the project statistical leader Responsible for writing statistical methodology section of the protocol,
Job Source: CytokineticsGilead Sciences, Inc.
San Mateo, CA, United States
Associate Director, Biostatistics - Inflammation United States - New Jersey - Toms River Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of pat
Job Source: Gilead Sciences, Inc.Gilead Sciences, Inc.
San Mateo, CA, United States
Associate Director, Biostatistics - Virology United States - New Jersey - Toms River Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patient
Job Source: Gilead Sciences, Inc.Gilead Sciences, Inc.
Foster City, CA, United States
Associate Director, Biostatistics - Inflammation page is loaded Associate Director, Biostatistics - Inflammation Apply locations United States - California - Foster City time type Full time posted on Posted 9 Days Ago job requisition id R0040448 For Current Gilead Employees and Contractor
Job Source: Gilead Sciences, Inc.Gilead Sciences, Inc.
Foster City, CA, United States
Associate Director - Biostatistician - Virology page is loaded Associate Director - Biostatistician - Virology Apply locations United States - California - Foster City time type Full time posted on Posted 8 Days Ago job requisition id R0037506 For Current Gilead Employees and Contractors:
Job Source: Gilead Sciences, Inc.Vera Therapeutics
Brisbane
Title: Associate Director, Biostatistics Location: Brisbane, California 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 immunologic diseases in order to change the standard of care
Job Source: Vera TherapeuticsRedwood City, CA, 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 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.
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
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Email Alert for Associate Director Biostatistics jobs in Redwood City, CA, United States
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