Associate Director Biostatistics

4 months ago

Redwood City, United States Meet Full time

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

  • Associate Director, Biostatistics and Data Science

    4 days ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job SummaryWe are seeking a highly skilled Associate Director, Biostatistics to join our team at Corcept Therapeutics. This is a critical role that will lead the execution of statistical components of our development programs.Key ResponsibilitiesCollaboration and LeadershipPartner with cross-functional teams, including Clinical Development, Regulatory,...

  • Director of Biostatistics

    5 days ago

    Redwood City, California, United States Meet Full time

    About MeetMeet is a global pharmaceutical company dedicated to creating innovative therapies to improve healthcare standards and address unmet medical needs worldwide. With over 100 years of scientific expertise and a presence in over 20 countries, our teams leverage cutting-edge science and technology to develop novel treatments in oncology and other...

  • Associate Director, Biostatistics

    4 weeks ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Associate Director, Biostatistics - InflammationUnited States - New Jersey - Toms RiverGilead 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 patients living...

  • Associate Director Biostatistics

    4 months ago

    Redwood City, United States Meet Full time

    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...

  • Director Biostatistics

    2 weeks ago

    redwood city, United States Meet Full time

    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...

  • Associate Director, Biostatistics

    2 months ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Associate Director, BiostatisticsUnited States - New Jersey - ParsippanyGilead 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 patients living with...

  • Director, Biostatistics

    1 month ago

    New York City, United States Eikon Therapeutics Full time

    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...

  • Director, Biostatistics

    3 weeks ago

    New York City, United States Eikon Therapeutics Full time

    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...

  • Sr. Director, Biostatistics

    1 month ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Sr. Director, BiostatisticsUnited States - California - Foster CityGilead 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 patients living with...

  • Director, Biostatistics and Data Science

    1 day ago

    Jersey City, New Jersey, United States Mitsubishi Tanabe Pharma Full time

    About the RoleMitsubishi Tanabe Pharma America is seeking a highly skilled and experienced Director, Biostatistics to join our team. As a key member of our organization, you will be responsible for managing biostatistics activities and developing tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning, and...

  • Head of Biostatistics

    2 weeks ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Senior Director of Biostatistical OperationsAt Gilead Sciences, we are dedicated to fostering a healthier world for everyone. For over 35 years, we have addressed significant health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovative therapies aims to enhance lives and ensure global access to these vital...

  • Associate Director, Biostatistics

    2 weeks ago

    New York City, United States Pfizer Full time

    Position is Onsite/HybridROLE SUMMARYDesign, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.Provide scientifically rigorous statistical expertise on:Projects and protocols in support of clinical development and for publication, presentation, access...

  • Endowed Chair, Department of Biostatistics and Epidemiology

    2 months ago

    Oklahoma City, Oklahoma, United States University of Oklahoma Health Sciences Center Full time

    Position: Endowed Chair, Department of Biostatistics and EpidemiologyDirect Supervisor: Dean, Hudson College of Public Health FTE: 100%Appointment Type: Tenure TrackRank/Title: Professor and Chair, Department of Biostatistics and EpidemiologyPrimary Location: University of Oklahoma Health Sciences, Oklahoma City, OKDeadline: Open until filled Position...

  • Associate Director of Accounting

    3 months ago

    Redwood City, United States Codexis, Inc. Full time

    Department 13 - Accounting & Finance Employment Type Full Time Location Redwood City, CA Workplace type Onsite DescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire an Associate Director of Accounting.  Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to...

  • Associate Director of Accounting

    3 months ago

    Redwood City, California, United States Codexis, Inc. Full time

    Department13 - Accounting & FinanceEmployment TypeFull TimeLocationRedwood City, CAWorkplace typeOnsiteDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire an Associate Director of Accounting. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop...

  • Associate Director Clinical Program Management

    3 months ago

    Redwood City, United States Meet Full time

    Meet has partnered with a Redwood City biotech leading in cutting-edge treatments in the cell/gene therapy space. Our client has a strong pipeline that has recently started to gain attention due to promising clinical data. They are looking to bring on an experienced Associate Director of Clinical Program Management to support the development of their...

  • Associate Director Clinical Program Management

    4 months ago

    Redwood City, United States Meet Full time

    Meet has partnered with a Redwood City biotech leading in cutting-edge treatments in the cell/gene therapy space. Our client has a strong pipeline that has recently started to gain attention due to promising clinical data. They are looking to bring on an experienced Associate Director of Clinical Program Management to support the development of their...

  • Associate Director of Quality Control

    3 months ago

    Redwood City, United States Codexis, Inc. Full time

    Department 64 - QC & Analytical Development Employment Type Full Time Location Redwood City, CA Workplace type Onsite DescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director of Quality Control. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology...

  • Associate Director of Quality Control

    3 months ago

    Redwood City, California, United States Codexis, Inc. Full time

    Department64 - QC & Analytical DevelopmentEmployment TypeFull TimeLocationRedwood City, CAWorkplace typeOnsiteDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director of Quality Control.Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover,...

  • Associate Director, Product Marketing

    1 month ago

    Redwood City, United States PubMatic Full time

    PubMatic (Nasdaq: PUBM) is an independent technology company maximizing customer value by delivering digital advertising’s supply chain of the future.PubMatic’s sell-side platform empowers the world’s leading digital content creators across the open internet to control access to their inventory and increase monetization by enabling marketers to drive...