Website HighTide Therapeutics
Founded in Shenzhen, China, HighTide Therapeutics is a global clinical-stage biopharmaceutical company focused on discovering and developing novel drugs to treat chronic liver diseases, gastrointestinal diseases, and metabolic disorders with high unmet needs. The company integrates expertise in disease biology, medicinal chemistry, clinical development, and regulatory affairs to advance its growing pipeline of drugs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH). The FDA has granted HTD1801 Fast Track Designation in both diseases.
JOB TYPE: Full-time
Location: US; Shenzhen/Shanghai, China
- Lead Biometrics team including biostatistics, data management, and programming of high performing to meet corporate regulatory, scientific, and business objectives by designing, and analyzing clinical studies using appropriate and innovative statistical methods
- Cooperate with the Clinical Development Team on statistical methods for data analyses of clinical trials, and provide statistical representation and leadership on project and protocol teams and to regulatory agencies
- Participate in the protocol development process, writing, review, and finalization of regulatory documents, such as Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the Statistical Analysis Report (SAR), clinical study report (CSR), etc.
- Establish top in class processes and standards for the generation and reporting of data, and lead verification of statistical programs, data sets used and statistical results in regulatory documents and other clinical data reports
- Work collaboratively with internal and external team members to coordinate the planning and execution of day to day biostatistics deliverables, and effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
- Bachelor degree or above in statistics/mathematics or related majors
- At least 8 years of preclinical statistics and relevant work experience
- Knowledge in drug development, data architecture, and research analytic software
- Skills in communication/negotiation, problem-solving, and multi-tasks handling
Contact: Lin Zhang