Alice Huilan L.
Director of Statistical Programming @Soleno Therapeutics, Inc.
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WORK HISTORY
Director of Statistical Programming @Soleno Therapeutics, Inc.
Led statistical programming efforts in NDA submission and information requests that led to the approval of the new drug Vykat for unmet needs for a rare disease. Built validated computing system and programming infrastructure from ground zero. Leading ongoing programming activities.
EDUCATION
Quantic School of Business and Technology
Executive MBA
Institute of Atmospheric Physics, Chinese Academy of Sciences
Master's degree, Atmospheric Physics and Dynamics
University of Wyoming
Master's degree, Atmospheric Sciences and Meteorology
ABOUT ALICE HUILAN L.
I am a strategic and empathetic leader with technical expertise in CDISC in supporting regulatory submissions, leading programming efforts in clinical trials for new drug development that advance health outcomes of humankind.My experience spans a range of functions including leading and overseeing programming activities, resource/project management, and cross functional communications. More specifically, I have estimated resource needs, built and led teams towards success for approved NDA/sNDA submissions with ISS/ISEs and phase I, II, IV studies. I have extensive experience in creating and reviewing SDTM/ADaM specs, datasets, ADRG, cSDRG, and define files. I am the go-to expert for challenging programming problems. I emphasize the importance of documentations and processes to ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP, CDISC), and best prepared for regulatory audits. I have initiated and contributed to the development of SOPs, Policies, and Standards. As a coach, mentor, and trainer in developing team members, I strongly believe in the power of continuous learning to reach one’s potential as well as achieve the company\'s best interest. I take pride in being part of the life science to help people improve life quality.CORE COMPETENCIESProficient: SAS, shell scripts, Excel, PowerPoint, Unix Windows, Fortune, SQLKnowledge: R, C/C++, Java Script, SPSS, MatlabExpertise: Statistical Programming, Regulatory Submissions, CDISC, Resource Planning & Management, Program Management, Regulatory AuditsLanguage: English/Mandarin/A Chinese Dialect
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