Director, Biostatistics – REMOTE


Penfield Search Partners

Our client is a thriving CRO whose clients range from large pharma to small biotech. They are currently recruiting for a Director of Biostatistics to provide statistical consulting to clients 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.

  • Provide statistical consulting to clinical study design and clinical development program
  • 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
  • Lead statistical methodology research and stay current on statistical methodology and drug development
  • 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

Desired for the role:

  • 8-10 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry
  • Direct participation in design, planning, conduct, analyses, and reporting of clinical trials
  • Direct participation in regulatory submission activities
  • Deep understanding statistical concepts and methodology related to clinical trials and drug development
  • Comprehensive knowledge on regulatory guidelines
  • Excellent organizational and project management skills
  • Excellent interpersonal and communication skills

Tagged as: Director Biostatistics - Remote