Director, Statistics

WuXi Apptec
Posted on

Type

Executive / senior industry position

 

Overview

The primary responsibilities of this position are to provide statistical consulting to clients in the biotech/pharmaceutical industry in their drug development programs with a focus on comprehensive data analysis strategies of clinical development, protocol/study design, regulatory submission strategies, regulatory communication, mentoring of other statisticians in generating analyses for clinical studies and regulatory submissions, and assist with business proposals.  This position assumes a supervision responsibility on job training for statistical personnel and inter-functional management, as well as staff performance review and budget planning.  

Responsibilities

  • Review and provide consultation to protocol preparation
  • Develop analysis plans and strategies for regulatory submissions
  • Lead regulatory submission strategy planning for statistics function
  • Write statistical reports to interpret analysis results for regulatory submissions, if needed
  • Review clinical study reports and other regulatory submission documents
  • Participate in integrated analysis strategy discussions with clients for regulatory submissions
  • Work with medical writers to assist with ISS/ISE reports preparation
  • Participate in regulatory communication
  • Identify and provide solutions to statistical issues
  • Mentor other statisticians in their support of client projects to ensure timely and high quality delivery of analysis package
  • Ensure that statistical personnel follow the standard operating procedures
  • Determine and maintain staff training curriculums
  • Identify department deficiencies/needs and propose new and/or revision of standard operating procedures
  • Assist with preparation of business proposals
  • Conduct performance evaluation on staff and participate in merit and budget discussions
  •  

 

Experience

  • 12-18 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry, including minimum of 6 years of supervision experience
  • Direct participation in design, planning, conduct, analyses, and reporting of clinical trials
  • Direct participation in regulatory submission activities

Skills

  • Comprehensive knowledge on regulatory guidelines
  • Excellent organizational and project management skills
  • Excellent interpersonal and communication skills

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

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More Information

Posted on

Type

Executive / senior industry position

San%20Diego%2C%20United%20States

San Diego , United States