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Clinical Operations and Regulatory Affairs, USA | 24 Feb 2021

Associate Director-Director, Biostatistics

Job Title: Associate Director-Director, Biostatistics Job Category: Exempt/Non-Exempt
Department/Group: Biometrics Travel Required: NA
Location: Florham Park, NJ Position Type: Full Time
Level/Salary Range: Mid-Level Hiring Manager: Sr. Director, Biostatistics

 

Job Description

Primary Function

  • This position serves as the Biostatistics lead supporting multiple programs in oncology across all stages of development. The position is responsible for providing compound level statistical expertise and leadership by assuming responsibility for innovative study designs, statistical methodology, data analysis, interpretation, and regulatory interactions and Discovery teams within Hutchison MediPharma (US) and teams in Shanghai, China

 

Major Responsibilities and Duties

  • Serves as a statistical lead for one or more oncology projects, facilitates the coordination of all statistical activities for these projects
  • Participates in the design and review of clinical protocols and case report forms for projects including the preparation of statistical considerations sections, sample size calculations, interim looks, randomization, and study design recommendations. Produces statistical section of clinical protocol
  • Creates and implements statistical analysis plans and specification documents
  • Carries out hands-on work associated with clinical studies and regulatory submissions
  • Communicates study results including internal communication as well as manuscripts, or oral presentations in scientific meetings
  • Participates in database design, data collection guidelines, and logic checks
  • Provides guidance to programmers and analysts on statistical procedures
  • Identifies and works with existing external statistical experts for consultation
  • Interacts and manages CROs with oversight activities, budgets, and timelines
  • Keeps abreast of regulatory and methodological topics
  • Develops and implements innovative statistical methodology
  • Demonstrates problem solving ability and critical thinking

 

Qualifications and Education Requirements

  • PhD. or M.S. in biostatistics, statistics, mathematics, or related field. At least 5 years of experience in pharma, biotech, or a related sector
  • Proficiency in statistical programming languages/software such as SAS, R, Spotfire etc.
  • Well-versed in the clinical and regulatory requirements for global submissions
  • Advanced knowledge of clinical study designs and statistical methodologies for analysis
  • Excellent interpersonal, leadership, and communication skills
  • US-based statistician who can help communicate with Chinese counterparts
  • Thorough knowledge of operational aspects of clinical trial conduct and overall drug development
  • Strong collaborative skills and ability to work with a cross-functional team
  • Strong project management skills