Cici Lu

Experience

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  More Technology International Inc

  Aug 2015 - Jun 2016

  Data Analyst

  • Interpreted models with statistical techniques to identify patterns in complex data sets.• Optimized primary models and developed data collection systems to improve statistical accuracy and data quality.• Defined and refined raw data and provided data analysis reports.

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  Cepheid

  Jun 2016 - Mar 2024

  • Led and managed all statistical related activities for multiple projects.• Applied knowledge and statistical guidance to the team members. • Coordinated project timelines for studies in collaboration with cross-functional teams.• Provided statistical input for the design of clinical studies in study synopsis and protocol.• Developed comprehensive statistical analysis plans to guide the analytical studies and clinical study.• Prepared statistical reports and sections of clinical study reports, emphasizing accuracy and adherence to regulatory reporting standards.• Collaborate with the regulatory affairs team to address any statistical related questions or concerns raised by the FDA and other regulatory agencies during the pre-submission and submission review process.• Contributed expertise to the refinement of data collection forms (Case Report Forms) and Electronic Data Capture (EDC) to ensure data quality and compliance with study protocols.• Collaborated with Clinical core team members on the enhanced data review. • Conducted annual statistics training sessions for cross-functional teams, fostering a collaborative and informed approach to software usage, study design and data analysis. Show less • Inputted statistical section of study protocols, including sample size and statistic method, ensuring precision and clarity.• Developed statistical analysis plans for Beta, Clinical, reproducibility/precision and ad-hoc studies.• Collaborated effectively with core team members in developing high-quality protocols, CRFs, schemas, and reports within established timelines.• Provided strategic statistical input for R&D initiatives, encompassing biomarker selection, algorithm development, and limit of detection (LOD).• Crafted detailed statistical analysis reports for studies, regulatory submissions, and scientific manuscripts.• Coordinated project timelines for statistical analysis in collaboration with cross-functional teams. Show less

  • Manager, Biostatistics

    Apr 2022 - Mar 2024

  • Senior Biostatistician

    Feb 2020 - Apr 2022

  • Biostatistician II

    Jun 2016 - Feb 2020
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  Inflammatix, Inc.

  Mar 2024 - Jan 2025

  Senior Manager, Biostatistics

  • Lead biostatistics team, providing oversight and guidance, while indirectly managing cross-functional teams as needed.• Contribute to clinical trial design by providing sample size calculations, statistical methodology, and input on case report forms, ensuring robust study protocols.• Serve as the primary biostatistician for all clinical trials, authoring statistical analysis plans and generating tables and figures listings.• Provide technical and statistical leadership on complex clinical projects, collaborating closely with cross-functional teams to ensure project success.• Collaborate with internal teams and regulatory agencies on statistical issues for submissions. Show less