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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.Meet
Redwood 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 w
Job Source: MeetGilead 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.EPM Scientific - Phaidon International
Menlo Park, CA, United States
We've just launched a search for a Senior Manager, Biostatistics with a legacy Bay Area biotech. This group is over 25 years old, and is one of our top clients. We've placed 25+ professioanls with this group and are excited for more! On that note, they're on a sharp growth trajectory sitting at ~350 employees when they were just over 100 this time
Job Source: EPM Scientific - Phaidon InternationalSouth 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, including sample size calculation
Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE
Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
Direct the activities of internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following CDISC standards.
Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.
Participate in operations meetings, project team meetings, and collaborate with other functional departments to address issues related to biostatistics.
Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports.
Perform ad hoc analysis and data validation.
Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, ADaM, statistical programming for TLFs, and data reporting.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Qualifications
PhD. in statistics/biostatistics with minimum 8 years of biopharmaceutical statistics experience; Master’s degree in statistics or biostatistics with a minimum of 10 years of experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry.
Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment
Knowledge of missing data handling, multiple comparisons, and simulation techniques.
Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
Good working knowledge of ICH, FDA and GCP regulations and guidelines
Strong leadership skills and team work spirit.
Experience in the neurology/cardiovascular therapeutic areasdesirable
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Email Alert for Director, Biostatistics jobs in South San Francisco, CA, United States
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