Senior/Director of Biostatistics - REMOTE

Highly Competitive Salary
  1. Permanent
  2. Analysis, Statistics, Informatics
  3. United States
Hoboken, USA
Posting date: 16 Aug 2023

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

Proclinical is seeking a Senior/Director of Biostatistics for a cutting-edge biotech company. This position has the opportunity to work remotely on the East Coast.

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
  • Ten years (12 years for masters) 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 cell gene therapies (CAR-T, iNEST)

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at +(1) 323-306-2409 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.