Ruixiao Lu

Ruixiao Lu Email and Phone Number

VP, Head of Biostats and Stats Programming; President-Elect 2024@BBSW; Fellow, ASA @ Alumis
Ruixiao Lu's Location
San Francisco Bay Area, United States, United States
Ruixiao Lu's Contact Details
About Ruixiao Lu

• Established Ph.D. statistical leader with extensive industry experiences in Clinical Development, Medical Affairs, RWE/RWD, and Outcome Research.• Fellow (elected), American Statistical Association• President-elect, BBSW; Chair of BBSW2024 Annual Conference (2024)• Demonstrated success in building, expanding, managing, and scaling up high performing teams of statisticians, programmers, data scientists/analysts, and clinical data managers.• Working knowledge of full lifecycle of precision medicine, from genomics, biomarker, diagnostics, to clinical trials for drug development, with application of advanced analytics and trial designs.• Regulatory experiences in oncology, immunology, infectious disease, and biomarker. • Built biostatistics/data management quality system from ground up. Experience in data standards used in regulatory submissions.• Strategic and agile leader. Effective communicator. Drive to results with a strong emphasis on quality.• Independently lead complex R&D and clinical projects, with efficiency and effectiveness in a multi-disciplinary team. • Data-driven decision maker with direct problem-solving skills in a business setting in the biotechnology/biopharmaceutical industry.

Ruixiao Lu's Current Company Details
Alumis

Alumis

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VP, Head of Biostats and Stats Programming; President-Elect 2024@BBSW; Fellow, ASA
Ruixiao Lu Work Experience Details
  • Alumis
    Vp, Head Of Biostatistics And Statisitical Programming
    Alumis Aug 2022 - Present
    South San Francisco, California, Us
    - Build and oversee the Biostatistics and Statistical Programming functions and quality systems.- Core team member for product portfolio and clinical/RWE programs. Member of Development Leadership Team. - Global regulatory interactions early to late phase- Business owner of company-wide computing environment with fit-for-purpose analytical applications; key stakeholder for analytical vendors and platforms evaluation and integration.- Alumis is a precision medicine company with the mission to transform the lives of patients with autoimmune diseases.
  • Bay Area Biotech-Pharma Statistics Workshop (Bbsw)
    President Elect
    Bay Area Biotech-Pharma Statistics Workshop (Bbsw) Jan 2024 - Present
    Founding Board Member, Secretary to the Board (2018- 2023)President-Elect (2024)Annual Conference Chair and Chair of Steering Committee (2024)BBSW is a 501C(3) organization in the San Francisco Bay Area, to promote connection, leadership, growth and impact of the statistics and quantitative science community. www.bbsw.org
  • American Statistical Association - Asa
    Fellow, Elected
    American Statistical Association - Asa 2024 - Present
    Alexandria, Va, Us
  • American Statistical Association - Asa
    Chair, Co-Founder, Pcrs
    American Statistical Association - Asa Jul 2023 - Present
    Alexandria, Va, Us
    Chair and co-founded the Partnership for Clinical Research and Statistics (PCRS) at ASA. PCRS serves as the primary platform at the ASA for collaborative partnership and programs with professional clinical organizations and FDA.
  • American Statistical Association - Asa
    Executive Committee Member, Caucus Of Industry Representatives (Cir)
    American Statistical Association - Asa May 2023 - Present
    Alexandria, Va, Us
    Established as part of the 2022 ASA Presidential Initiatives, CIR at ASA provides resources for industry statisticians and data scientists to successfully advocate for the discipline.https://community.amstat.org/caucusofindustryrepresentatives/homehttps://magazine.amstat.org/blog/category/caucus-of-industry-representatives/
  • American Statistical Association - Asa
    Treasurer, Member Of Executive Committee And Board Of Directors
    American Statistical Association - Asa Jan 2020 - Dec 2023
    Alexandria, Va, Us
    ASA Board Member to manage financial committees (investment, audit, budget, development). Appointed for the term 2020-2023.
  • American Statistical Association - Asa
    Vice Chair, Council Of Chapters Governing Board
    American Statistical Association - Asa Jul 2018 - Dec 2022
    Alexandria, Va, Us
    Vice Chair of District 6, American Statistical Association Council of Governing Board (ASA-COCGB). The District 6 consists of 15 chapters from 11 states with about 2,000 members on the west coast of US. Appointed for 2018-2019, and then elected for the term 2020-2022.
  • Dahshu
    Co-Founder, Board Member, And Vp Of Operation And Communication
    Dahshu Jun 2015 - Present
    San Jose, Ca, Us
    Co-Founder of DahShu, a 510(c)(3) non-profit organization that promotes research and education in data sciences. Please visit us at:www.dahshu.orghttps://www.linkedin.com/company/DahShu
  • Quantum Leap Healthcare Collaborative
    Vice President, Head Of Statistics, Data Management & Data Science
    Quantum Leap Healthcare Collaborative Dec 2020 - Aug 2022
    San Francisco, Ca, Us
    Responsibilities: ✓ Functional head overseeing the department of Statistics, Clinical Data Management & Data Science, and end-to-end analytical pipeline.✓ Built the team from ground up. ✓ Built the functional quality system from group up. ✓ Strategic thinker and key stakeholder in business development and strategy for all clinical programs including Breast Cancer and COVID.✓ Team supports the large-scale platform trials such as I-SPY Breast Cancer and I-SPY COVID using master protocols in phase 1 and phase 2 drug development to rapidly develop targeted therapies. ✓ Built relationships with the I-SPY Consortium Leadership and collaborated on publicationsand congress presentations as co-authors/presenter.About Quantum Leap Healthcare Collaboratives (QLHC): QLHC is the sponsor for the I-SPY trials (Breast Cancer and COVID), BreastCancerTrials.org, and CTMatch, integrating high-impact clinical research with patient care. - Accelerate the development of safe, effective, personalized treatment, detection and prevention options and improve the delivery of clinical care. - The core of the I-SPY program is the ground-breaking I-SPY 2 platform trial using master protocol, with advanced analytical and operational pipelines.
  • Exact Sciences
    Director, Clinical Biostatistics (Exas Acquired Genomic Health In Nov.2019)
    Exact Sciences Nov 2019 - Dec 2020
    Madison, Wisconsin, Us
    • Build, lead and manage a team of biostatisticians/data scientists and statistical programmers as the functional head of Clinical Biostatistics and Statistical Programming.• Direct and oversee statistical activities in support of clinical studies, algorithm development, preparation of final study reports, and conference abstracts and peer-reviewed manuscripts. • Strategic and agile leader with influence in the local and national statistical community.• Drive functional process needs and standardization, and define and implement best practices and departmental policies.• Define and justify functional headcount requirements, recruiting and hiring decisions. Onboard new hires.
  • Genomic Health
    Director, Clinical Biostatistics
    Genomic Health Feb 2019 - Nov 2019
    Redwood City, Ca, Us
    • Direct a team of biostatisticians and statistical programmers; oversee statistical activities in support of clinical studies, algorithm development, preparation of final study reports, and conference abstracts and peer-reviewed manuscripts.• Represent the statistics function for clinical programs.• Drive functional process needs and standardization, and defining and implementing best practices for Clinical Biostatistics.• Strategic and emerging leader with influence in the local and national statistical community.
  • Genomic Health
    Lead Program Biostatistician (Director Equivalent)
    Genomic Health Aug 2017 - Jan 2019
    Redwood City, Ca, Us
    • Represent the statistics function on project teams for clinical development programs, providing strategic input to the study design and clinical plans. • Strategic leader within the company. Able to communicate effectively throughout all levels of organization, and work effectively in multi-disciplinary teams. • Demonstrated success in interacting with and exerting significant influence on internal and external collaborators on study design, analysis methods, and interpretation of study results.• Manage and oversee statistical programming activities.
  • Genomic Health
    Principal Biostatistician, Medical Affairs, Clinical Biostatistics
    Genomic Health Jun 2014 - Jul 2017
    Redwood City, Ca, Us
    • Develop and implement of U.S. and International Medical Affairs strategies.• Support design, analysis and publication of results from Medical Affairs studies; domestic and international reimbursement submissions; planning and development of publications, product messaging, marketing materials, and education and training materials.• Create networks with external clinical and statistical collaborators. • Influence decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with the company strategic interests.
  • Novartis
    Principal Biostatistician
    Novartis 2009 - 2014
    Basel, Baselstadt, Ch
    Lead statistician on clinical studies for IVD product registration, FDA 510(k) submissions, and post-market medical affairs activities. Novartis Diagnostics Business Unit was sold to Grifols Diagnostics Solution in Feb. 2014.
  • Affymetrix
    Biostatistician
    Affymetrix Jan 2008 - Sep 2009
    Santa Clara, California, Us
    Mostly non-clinical statistical work.Lead statistician for the analysis pipeline for the Axiom SNP calling algorithm and implementation using Perl and R. Working with product scientists on DOE to optimize automation processes.
  • Tethys Bioscience, Inc.
    Biostatistics Consultant
    Tethys Bioscience, Inc. 2007 - 2007
    Emeryville, Ca, Us
  • Agilent Technologies
    Intern
    Agilent Technologies Jun 2005 - Sep 2005
    Santa Clara, Ca, Us

Ruixiao Lu Skills

Biostatistics Clinical Trials Biotechnology R Genomics Bioinformatics Clinical Study Design Sas Biomarkers Statistical Modeling Fda Clinical Research Clinical Development Survival Analysis Genetics Data Mining Predictive Modeling U.s. Food And Drug Administration Experimental Design Diagnostics Blood Testing Statistical Consulting Dna Sequencing Ivd Blood Bank Public Health

Ruixiao Lu Education Details

  • University Of California, Davis
    University Of California, Davis
    Statistics (With Emphasis In Biostatistics)
  • Peking University
    Peking University
    School Of Mathematical Sciences

Frequently Asked Questions about Ruixiao Lu

What company does Ruixiao Lu work for?

Ruixiao Lu works for Alumis

What is Ruixiao Lu's role at the current company?

Ruixiao Lu's current role is VP, Head of Biostats and Stats Programming; President-Elect 2024@BBSW; Fellow, ASA.

What is Ruixiao Lu's email address?

Ruixiao Lu's email address is rl****@****ces.com

What is Ruixiao Lu's direct phone number?

Ruixiao Lu's direct phone number is +165056*****

What schools did Ruixiao Lu attend?

Ruixiao Lu attended University Of California, Davis, Peking University.

What skills is Ruixiao Lu known for?

Ruixiao Lu has skills like Biostatistics, Clinical Trials, Biotechnology, R, Genomics, Bioinformatics, Clinical Study Design, Sas, Biomarkers, Statistical Modeling, Fda, Clinical Research.

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