Location: China (Remote / Home-based) Industry: Pharmaceutical / CRO / Drug discovery
Responsibilities:
Lead biostatistics / biometrics efforts in a clinical research organization, optimizing workflows and enhancing data quality for strategic advancements
Provide direction to ensure department goals’ alignment with overall corporate objectives
Apply deep biostatistical expertise for precise methodologies in diverse clinical trials, and lead advanced analysis for valuable insights
Support BD Team by helping BD team to understand clients’ statistical needs to establish strong client relationship, and contribute to business proposal content as and when required
Ensure adherence to FDA / CFDA / corporate adopted guidelines; implement rigorous quality assurance processes for accuracy and reliability
Foster collaboration with cross-functional teams, aligning statistical strategies with trial goals; provide expert guidance (when required) to support informed decision making
Provide mentorship to team, develop / offer training and career growth opportunities to team members
Qualifications:
Master's degree or higher in epidemiology, biostatistics, or medical pharmacy, with 8+ years of relevant work experience in handling diverse clinical trials related projects in pharmaceutical / clinical research organization (CRO) industry
Demonstrates extensive knowledge in clinical research, biostatistics, and data management
In depth knowledge of regulatory guidelines, including FDA/CFDA biostatistics-related regulations
Excellent communicator with good interpersonal, organizational and analytical skills