Director Biostatistics

2 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

  • Director of Biostatistics and Programming

    2 weeks ago

    Redwood City, California, United States Zymeworks Full time

    Job SummaryZymeworks is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative biotherapeutics. We are seeking a highly skilled Director of Biostatistics and Programming to join our team in Redwood City, CA. This is a hybrid role with a minimum of 3 days per week onsite.Key ResponsibilitiesDevelop and...

  • Biostatistics Director

    4 weeks ago

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

    Job Title: Director, BiostatisticsCompany Overview:Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, with a rich history spanning over 300 years. Our parent company is a research-driven pharmaceutical company that has made significant contributions to medical breakthroughs globally....

  • Director Biostatistics

    2 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 of Biostatistics

    4 weeks ago

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

    Overview:Mitsubishi Tanabe Pharma America, Inc. is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation in Japan, a research-driven pharmaceutical company with a storied reputation over 300 years in the making. Our parent company has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis, diabetes...

  • Associate Director Biostatistics

    5 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...

  • Senior Biostatistics Director

    2 weeks ago

    Foster City, California, United States Gilead Sciences Full time

    Biostatistics Leadership Opportunity at Gilead SciencesWe are seeking a highly skilled Biostatistics professional to join our team at Gilead Sciences. As a Biostatistics Lead, you will play a critical role in the development of life-changing scientific innovations.Key Responsibilities:Lead biostatistical analysis and reporting for clinical development...

  • Biostatistics Leadership Position

    3 weeks ago

    Jersey City, New Jersey, United States Mitsubishi Chemical Group Full time

    Job Title: Director, BiostatisticsMitsubishi Chemical Group is seeking a highly skilled and experienced Director, Biostatistics to lead our biostatistics team and drive the development of innovative statistical solutions.Key Responsibilities:Develop and implement biostatistics strategies to support clinical development activitiesProvide statistical...

  • Senior Biostatistics Director

    3 weeks ago

    Foster City, California, United States Gilead Sciences Full time

    Job SummaryWe are seeking a highly skilled Associate Director, Biostatistics to join our team at Gilead Sciences. As a key member of our Virology department, you will be responsible for providing statistical leadership and expertise to support the development and commercialization of our virology compounds.Key ResponsibilitiesProvide statistical leadership...

  • Oncology Medical Director, MRD

    4 weeks ago

    Redwood City, California, United States Exact Sciences Full time

    Transforming Cancer Care with Exact SciencesAt Exact Sciences, we're pioneering a new era in cancer prevention, detection, and treatment. As an Oncology Medical Director, MRD, you'll play a pivotal role in shaping our molecular residual disease (MRD) commercialization strategies. This is an exceptional opportunity to leverage your expertise in molecular...

  • Medical Director, Research Learning

    5 days ago

    Kansas City, Missouri, United States Children's Mercy Hospital (MO) Full time

    Job SummaryThe Medical Director of the Research Learning Center at Children's Mercy Hospital is responsible for nurturing, developing, and mentoring clinician scientists in partnership with academic chairs, the Children's Mercy Research Institute leadership, and the Office of Faculty Development.This leadership position requires administrative skills to...

  • Director of Data and Product Analytics

    7 days ago

    new york city, United States TekVizor Full time

    Director of Data and Analytics - ProductLocation: New York City Metropolitan Area (On-site/Hybrid)New York City, NY*Unfortunately, we are unable to sponsor at this time.Hiring an experienced Director of Data Science & Analytics to manage a product team. You will provide leadership for the delivery of Advanced Analytics to build analytics data pipelines,...

  • Director of Analytics – ML/AI Products

    2 months ago

    new york city, United States TekVizor Full time

    Director of Analytics – ML/AI Product ManagementLocation: New York City Metropolitan Area (On-site/Hybrid)New York City, NY*Unfortunately, we are unable to sponsor at this time.Hiring an experienced Director of Product Analytics to manage a 10-person team within a growing technology company. You will provide leadership for the delivery of Advanced...

  • Director of Analytics – ML/AI Products

    3 weeks ago

    new york city, United States TekVizor Full time

    Director of Analytics – ML/AI Product ManagementLocation: New York City Metropolitan Area (On-site/Hybrid)New York City, NY*Unfortunately, we are unable to sponsor at this time.Hiring an experienced Director of Product Analytics to manage a 10-person team within a growing technology company. You will provide leadership for the delivery of Advanced...

  • Division Director – Health Services

    4 weeks ago

    Kansas City, United States Children's Mercy Hospital Full time

    The Department of Pediatrics at Children’s Mercy seeks a creative and scholarly leader to serve as Division Director of of Health Services and Outcomes Research (HSOR). The Division Director will be responsible for leading the educational, research and quality missions of HSOR, an academic division focused on conducting high quality, impactful research...

  • Division Director – Health Services

    4 months ago

    Kansas City, United States Children's Mercy Hospital (MO) Full time

    The Department of Pediatrics at Children’s Mercy seeks a creative and scholarly leader to serve as Division Director of of Health Services and Outcomes Research (HSOR). The Division Director will be responsible for leading the educational, research and quality missions of HSOR, an academic division focused on conducting high quality, impactful research...

  • Division Director

    1 week ago

    Kansas City, United States Children's Mercy Hospitals and Clinics Full time

    DIVISION DIRECTOR – ENDOCRINOLOGY CHILDREN’S MERCY KANSAS CITY, MO The Department of Pediatrics at Children’s Mercy seeks a creative and scholarly leader to serve as Division Director of Endocrinology. The Division Director will be responsible for leading the clinical, educational, research and quality missions of a comprehensive academic...

  • Division Director

    1 week ago

    Kansas City, United States Children's Mercy Hospitals and Clinics Full time

    DIVISION DIRECTOR – ENDOCRINOLOGY CHILDREN’S MERCY KANSAS CITY, MO The Department of Pediatrics at Children’s Mercy seeks a creative and scholarly leader to serve as Division Director of Endocrinology. The Division Director will be responsible for leading the clinical, educational, research and quality missions of a comprehensive academic...

  • Division Director – Endocrinology

    5 months ago

    Kansas City, United States Children's Mercy Hospital (MO) Full time

    DIVISION DIRECTOR – ENDOCRINOLOGYCHILDREN’S MERCY KANSAS CITY, MOThe Department of Pediatrics at Children’s Mercy seeks a creative and scholarly leader to serve as Division Director of Endocrinology. The Division Director will be responsible for leading the clinical, educational, research and quality missions of a comprehensive academic endocrinology...

  • Medical Science Director

    3 weeks ago

    Jersey City, New Jersey, United States Mitsubishi Chemical Group Full time

    Job Title: Director, Medical ScienceMitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which boasts a storied reputation spanning over 300 years. Our parent company, a research-driven pharmaceutical company, has tirelessly pursued medical breakthroughs with global reach. MTPC has...

  • Division Director

    1 week ago

    Kansas City, United States Children's Mercy KC Full time

    Thanks for your interest in Children's Mercy! Do you envision finding a meaningful role with an inclusive and compassionate team? At Children’s Mercy, we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference, which is why we have been recognized by...