Current jobs related to Senior Director, Biostatistics and Data Science - Emeryville, California - Kyverna Therapeutics, Inc.
-
Director of Safety Science
2 weeks ago
Emeryville, California, United States BeiGene Full timeJob Title: Director, Safety ScientistJob Summary:The Director, Safety Scientist is a critical role within BeiGene, responsible for leading the detection of safety signals, evaluation of safety data, and assessment of safety risks. This position requires a strong clinical and scientific background, with expertise in pharmacovigilance and regulatory...
-
Director of Safety Science
2 weeks ago
Emeryville, California, United States BeiGene Full timeJob DescriptionGeneral Description:The Director of Safety Science will support assigned compounds in conjunction with Product Safety Leads (PSLs) and leverage clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic...
-
Senior Statistical Programmer
2 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeBiostatistics LeadKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.The company's therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory...
-
Health Sciences Senior Consultant
1 month ago
Emeryville, California, United States Ramboll Group AS Full timeJob Title: Health Sciences Senior ConsultantRamboll is seeking a highly skilled Health Sciences Senior Consultant to join our team in Emeryville, CA.Job Summary:We are looking for a talented individual to assist with human health risk assessments for hazardous waste sites, Brownfield redevelopment sites, ambient air releases, and indoor air sources, as well...
-
Data Engineering Director
2 weeks ago
Emeryville, California, United States The Rockridge Group Full timeJob OverviewThe Rockridge Group is seeking a seasoned Data Engineering Director to lead our data analytics and data engineering departments. As a key member of our team, you will be responsible for developing and implementing a data strategy that aligns with our business vision and objectives.Key ResponsibilitiesDefine and implement a data strategy that...
-
Clinical Science Director
7 days ago
Emeryville, California, United States BeiGene Full timeJob Summary:The Associate Director – Clinical Science will play a key role in supporting BeiGene Clinical and Medical assets by successfully executing clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners.Key Responsibilities:Facilitate the...
-
Associate Director, Clinical Science
2 weeks ago
Emeryville, California, United States BeiGene Full timeJob Summary:The Associate Director – Clinical Science will play a key role in supporting BeiGene Clinical and Medical assets by successfully executing clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners.Key Responsibilities:• Facilitate the...
-
Clinical Data Management Director
2 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeJob Title: Clinical Data Management DirectorKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our innovative therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of...
-
Director of Strategic Evidence
4 weeks ago
Emeryville, California, United States BeiGene Full timeJob Title: Director, Strategic EvidenceWe are seeking a highly skilled Director, Strategic Evidence to join our team at BeiGene. As a key member of our organization, you will play a critical role in developing and driving evidence streams that are strategic, customer-focused, and optimize patient care decision-making processes.Key Responsibilities:Develop...
-
Emeryville, California, United States BeiGene Full timeJob SummaryThe Senior Quality Director, Commercial Small Molecule will lead the quality management process for commercial small molecule products, ensuring compliance with regulatory requirements and BeiGene standards. This role will oversee the quality team, manage quality issues, and implement effective CAPA processes.Key ResponsibilitiesLead the quality...
-
Emeryville, California, United States BeiGene Full timeJob Title: Senior Director, Global Commercial Lead, BTK CDACBeiGene is seeking a highly motivated and experienced Senior Director to lead the commercial strategic initiatives for our hematology pipeline as the Global Commercial Lead, BTK CDAC.Key Responsibilities:Develop and execute global commercial strategies for BTK CDAC, focusing on key milestones such...
-
Associate Director, Safety Scientist
7 days ago
Emeryville, California, United States BeiGene Full timeJob DescriptionOverviewThe Associate Director, Safety Scientist plays a critical role in supporting assigned compounds in conjunction with Product Safety Leads (PSLs) and leveraging clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required...
-
Safety Scientist Director
2 weeks ago
Emeryville, California, United States BeiGene Full timeJob DescriptionJob Title: Director, Safety ScientistJob Summary: We are seeking a highly skilled and experienced Director, Safety Scientist to join our team at BeiGene. The successful candidate will be responsible for leading the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and...
-
Senior Director of Medical Affairs
1 week ago
Emeryville, California, United States Sutter Health Full timeWe are seeking a highly skilled and experienced Senior Director of Medical Affairs to join our team at Sutter Health.Job Summary:The Senior Director of Medical Affairs will be responsible for leading the strategic, clinical, and programmatic direction of the Same Day Care Service Line across Sutter Health.Key Responsibilities:Develop and implement strategies...
-
Senior Project Engineer
2 weeks ago
Emeryville, California, United States IPS-Integrated Project Services, LLC Full timeJob DescriptionAt IPS, you'll apply your knowledge, skills, and passion to make a difference in the lives of people, by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities.We are looking for a talented Senior Project Engineer to join our dedicated team located at our project site in...
-
Housing Program Manager
2 weeks ago
Emeryville, California, United States St Mary's Center Full timeJob SummaryWe are seeking a highly skilled and experienced Housing Program Manager to join our team at St. Mary's Center. The successful candidate will provide leadership and accountability to an interdisciplinary team of professional and paraprofessional case managers and housing navigators working to support Seniors in becoming and remaining housed.Key...
-
Senior Manager
2 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeJob SummaryKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company's therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory...
-
Associate Director, Safety Expert
7 days ago
Emeryville, California, United States BeiGene Full timeThe Associate Director, Safety Expert supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting.Physicians in this role are also...
-
Data Scientist
1 month ago
Emeryville, California, United States The Rockridge Group Full timeJob DescriptionWe are seeking a highly skilled Data Engineer to join our team at The Rockridge Group.Key Responsibilities:Develop and maintain large-scale data systems and pipelinesDesign and implement data architectures to support business intelligence and analyticsCollaborate with cross-functional teams to integrate data into business applicationsEnsure...
-
Senior Director of Medical Affairs
2 weeks ago
Emeryville, California, United States Sutter Health Full timeJob Summary:We are seeking a highly experienced Senior Director of Medical Affairs to lead our medical staff services team. The ideal candidate will have a strong background in medical management and a proven track record of success in leading high-performing teams.Key Responsibilities:Provide strategic leadership and direction to the medical staff services...
Senior Director, Biostatistics and Data Science
2 months ago
Kyverna Therapeutics, Inc. is a pioneering biopharmaceutical company dedicated to developing innovative cell therapies for patients suffering from autoimmune diseases. As a Senior Director, Biostatistics and Data Science, you will play a crucial role in shaping the company's clinical development strategies and ensuring the success of our global clinical trials.
Key Responsibilities- Strategic Leadership: Provide expert guidance on biostatistics and data science for global clinical development, creating and implementing biostatistics standards that drive short-term and long-term planning.
- Statistical Analysis Execution: Collaborate with cross-functional teams to design, execute, and analyze complex clinical studies, generating high-quality statistical methods and results for study reports and contributing to data interpretation and decision-making processes.
- Data Collection and Design Support: Offer guidance on data collection, design, and analysis for global studies, ensuring efficient medical and safety data review and monitoring, including DSMB meetings.
- Clinical Studies Management: Work closely with CROs to plan, monitor, and analyze global clinical studies, coordinating the development and review of statistical aspects of regulatory submissions.
- Clinical Development and Regulatory Interaction: Provide biostatistical input for overall clinical development strategies, protocol design, statistical analysis plans, and regulatory interactions, handling briefing books, submissions, and addressing requests and positions from regulatory agencies.
- Clinical Study Documentation Preparation: Prepare clinical study documents for eCTD clinical modules, familiar with CDISC standards, IWRS, SDTM, ADaM Specs, and review define documents.
- Development and Commercialization Support: Contribute statistical expertise to support development and commercialization strategies, including post hoc analyses and interpretation of results.
- Cross-Functional Collaboration: Work closely with global medical, clinical operations, regulatory, and safety teams to ensure efficient execution of global clinical trials.
- Ph.D. degree in Biostatistics, Statistics, or related field.
- At least 10 years' experience, responsible for biostatistics in clinical trials across different therapeutic indications with in-depth experience in interaction with regulatory agencies, preferably in immunology and neurology. Successful submission a big plus.
- Extensive experience collaborating with scientific teams to design robust and complex clinical trials with proven success in accelerated approval.
- Proficiency in using statistical software such as R, SAS for data analysis and modeling. Familiar with a variety of power calculation settings. Hands-on experience currently on generating TFLs.
- Familiarity with complex and novel statistical methods that apply to applicable clinical trials, such as adaptive Bayesian design, counterfactual design in RWD.
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail.
