LinHR's client - a clinical development CRO dedicated to providing high-quality services including regulatory affairs, medical affairs, clinical operation, data management, statistical analysis, programming, and biological sample analysis. They are the most trusted and fastest-growing clinical trial service provider/partner for both domestic and overseas sponsors.
They are looking for a Associate Director​, Statistics​ (Full Time) in Piscataway, NJ, United States.

Responsibilities  

  • Provide statistical inputs/consultants on trial design, protocol and CRF development, perform sample size calculation, interact with clients with regard to statistical issues.
  • Authoring and review of statistical analysis plans and statistical methodology sections in clinical protocols in different therapeutic areas from phase I to phase IV.
  • Manage team activities including training and mentoring, issues resolving, quality control and timely completion of project deliverables, ensure on-time deliver best value and high-quality service.
  • Develop, review and improve standard operation procedures (SOPs), working instructions (WIs), standard templates and procedures to ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards and improve productivity and efficiency of the team.
  • Maintain a positive, collaborative, results orientated work environment, build partnerships and teamwork, communicate to team in an open, transparent and objective manner.​

Requirements​

  • MS or PhD in Statistics, Biostatistics or related field. PhD with 6+ years or MS with 8+ years of pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.
  • Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
  • Demonstrated ability to identify areas of statistical research in improving the design, analysis and reporting of clinical study.  
  • Strong oral and written communication skills, with ability to communicate effectively throughout all levels of the organization.
  • Demonstrated capability to set clear priorities and effectively manage multiple projects.  
  • Timeline adherence, reliability, efficiency, attention to details, quality driven.