Associate Director Biostatistics


Penfield Search Partners

Our client is a global pharmaceutical company with a diverse and well-developed pipeline that spans several therapeutic areas. They are seeking an Associate Director of Biostatistics to play a key role in the development of Nephrology compounds. This is a visible, hands-on role that is also strategic your input will be very important in effectively and efficiently developing processes for approval of these drug products. There will be a heavy focus on protocol development and on creative ways to look at data, and you will be encouraged to take a leadership role within your dedicated programs.

  • Provide statistical input in the clinical development plan and protocols and conduct statistical analyses and summary of clinical studies and integrated database to help advance the drug development process
  • Provide statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis methods
  • Develop detailed Statistical Analysis Plan (SAP) to document technical considerations
  • Review protocol outlines and protocols and produces randomization codes
  • Review CRF, database structure; edit-check specifications, final tables, listings, and figures and other clinical documents
  • Perform exploratory analyses for marketing and Phase IV studies as well as statistical analyses for abstracts, posters and publications
  • Handle FDA or other regulatory agencies contact and regulatory meetings including AdComms
  • Interface with FDA statistical reviewers and serve on the rapid response team to address inquiries during NDA review
  • Provide statistical input on Clinical Development Plan regarding primary efficacy endpoints, go/no-go decision criteria, size of studies, and statistical methodologies
  • Represent clients (internal OPDC, OFRI, OPJ-C, and external partners) at FDA meetings, FDA advisory boards, or other scientific meetings
  • Evaluate new statistical methodologies and AI/Machine Learning software and their potential applications in clinical trial design and analysis as well as HEOR, RWD/RWE insight and analytics
  • Assist in departmental planning and resource allocation and mentoring staff
  • PhD/MS in Statistics or Biostatistics
  • 7+ years of experience in the pharmaceutical industry

Tagged as: Associate Director, Biostatistics