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.
LinHR is committed to providing accommodations for people with disabilities. If you require an accommodation, we will work with you to meet your needs. Accommodation will be provided in all parts of the hiring process as required under LinHR's Employment Accommodation Policy. Applicants need to make their needs known in advance. ​