Associate Director, Biostatistics

Highly Competitive Salary
  1. Permanent
  2. Statistics, Data Management, Informatics
  3. United States
Boston, USA
Posting date: 12 Oct 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking an Associate Director, Biostatistics for a cutting-edge biotech company located in Boston, MA.

Must be eligible to work in the US.

Job Responsibilities:

  • Represent Statistics in cross-functional project and study teams in multiple projects
  • Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
  • Perform sample size calculations, develop statistical analysis plans and lead TLF development
  • Perform statistical analyses and validate analysis results
  • Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
  • Develop, implement and improve statistical processes and standards
  • Support and participate in the development of departmental strategies
  • Interact with global regulatory authorities

Skills and Requirements:

  • PhD or Masters in Statistics or Biostatistics
  • 6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience
  • Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
  • Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
  • Preferred experience with clinical study designs in Oncology or Infectious Diseases

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.